A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

Purpose

This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

Condition

  • Ovarian Carcinoma

Eligibility

Eligible Ages
Between 35 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Individuals 35-50 years of age, inclusive - Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted - At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present - Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required - Patients may be premenopausal or menopausal - Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) and CA-125 within 180 days of registration - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry - Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future

Exclusion Criteria

  • Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed. - Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma - Patients medically unfit for the planned surgical procedure - Patients with abnormal screening tests (pelvic ultrasound, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days - An abnormal pelvic ultrasound is defined as morphologic or structural variations suspicious for ovarian malignancy. Complex cystic lesions felt to represent a benign lesion are not exclusionary. Simple cysts of any size are not exclusionary - An abnormal CA-125 is defined as a level > 50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40U/ml for premenopausal individuals who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level > 35 U/ml in postmenopausal individuals

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a non-randomized prospective trial to determine if bilateral salpingectomy (BLS) is non-inferior to bilateral salpingo-oophorectomy (BSO) in terms ovarian, primary peritoneal, and fallopian tube cancer risk among gBRCA1m carriers between 35 and 50 years old. Individuals choose the treatment they want to receive in collaboration with their physician(s).
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group I (bilateral salpingectomy) 		Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.
  • Procedure: Bilateral Salpingectomy
    Undergo bilateral salpingectomy
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Procedure: Transvaginal Ultrasound
    Undergo transvaginal ultrasound
    Other names:
    • transvaginal sonography
    • TVS
    • TVU
  • Procedure: Ultrasound Imaging
    Undergo pelvic ultrasound
    Other names:
    • 2-Dimensional Grayscale Ultrasound Imaging
    • 2-Dimensional Ultrasound Imaging
    • 2D-US
    • Ultrasonography
    • Ultrasound
    • Ultrasound Test
    • Ultrasound, Medical
    • US
Active Comparator
Group II (bilateral salpingo-oophorectomy) 		Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.
  • Procedure: Bilateral Salpingectomy with Oophorectomy
    Undergo bilateral salpingo-oophorectomy
    Other names:
    • bilateral salpingo-oophorectomy
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Procedure: Transvaginal Ultrasound
    Undergo transvaginal ultrasound
    Other names:
    • transvaginal sonography
    • TVS
    • TVU
  • Procedure: Ultrasound Imaging
    Undergo pelvic ultrasound
    Other names:
    • 2-Dimensional Grayscale Ultrasound Imaging
    • 2-Dimensional Ultrasound Imaging
    • 2D-US
    • Ultrasonography
    • Ultrasound
    • Ultrasound Test
    • Ultrasound, Medical
    • US

Recruiting Locations

University of Alabama at Birmingham Cancer Center
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Alaska Women's Cancer Care
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Helen F Graham Cancer Center
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First Physicians Group - Urology Robotic and Minimally Invasive Surgery
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Grady Health System
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Rush - Copley Medical Center
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Barrington, Illinois 60010
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Bloomington, Illinois 61701
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Chicago, Illinois 60611
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Chicago, Illinois 60612
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Chicago, Illinois 60637
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Danville, Illinois 61832
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Downers Grove, Illinois 60515
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Effingham, Illinois 62401
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Elgin, Illinois 60123
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Geneva, Illinois 60134
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Naperville, Illinois 60540
Contact:
Site Public Contact
630-646-6075

UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Bromenn Regional Medical Center
Normal, Illinois 61761
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Carle Cancer Institute Normal
Normal, Illinois 61761
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622

University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621

Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois 60585
Contact:
Site Public Contact
630-646-6075
Cancerresearch@edward.org

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

The Carle Foundation Hospital
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

IU Health North Hospital
Carmel, Indiana 46032
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Goshen Center for Cancer Care
Goshen, Indiana 46526
Contact:
Site Public Contact
574-364-2973
cccois@goshenhealth.com

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225

University of Kansas Clinical Research Center
Fairway, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Baptist Health Corbin
Corbin, Kentucky 40701
Contact:
Site Public Contact
859-523-1934

Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky 41017
Contact:
Site Public Contact
859-301-4730
barbara.logan@stelizabeth.com

Baptist Health Lexington
Lexington, Kentucky 40503
Contact:
Site Public Contact
859-260-6425

Baptist Health Louisville
Louisville, Kentucky 40207
Contact:
Site Public Contact
502-897-8592
Cbcresearch@bhsi.com

Norton Suburban Hospital and Medical Campus
Louisville, Kentucky 40207
Contact:
Site Public Contact
502-629-3465

Baptist Health Paducah
Paducah, Kentucky 42003
Contact:
Site Public Contact
270-575-2928

West Jefferson Medical Center
Marrero, Louisiana 70072
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Louisiana State University Health Science Center
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

University Medical Center New Orleans
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Willis-Knighton Medical and Cancer Center
Shreveport, Louisiana 71103
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Maine Medical Center-Bramhall Campus
Portland, Maine 04102
Contact:
Site Public Contact
207-885-7565

Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8090
wrighd@mmc.org

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100

UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100

Baystate Medical Center
Springfield, Massachusetts 01199
Contact:
Site Public Contact
413-794-3565
tamara.wrenn@baystatehealth.org

Corewell Health Dearborn Hospital
Dearborn, Michigan 48124
Contact:
Site Public Contact
248-551-7695

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan 48336
Contact:
Site Public Contact
248-551-7695

McLaren Cancer Institute-Flint
Flint, Michigan 48532
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Borgess Medical Center
Kalamazoo, Michigan 49048
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Oakland Colon Rectal Associates
Royal Oak, Michigan 48067
Contact:
Site Public Contact
248-551-7695

Cancer Care Associates PC
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Comprehensive Medical Center PLLC
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Hematology Oncology Consultants PC
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Oakland Medical Group
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Premier Hematology Oncology Care
Sterling Heights, Michigan 48312
Contact:
Site Public Contact
248-551-7695

Michigan Institute of Urology-Town Center
Troy, Michigan 48084
Contact:
Site Public Contact
248-551-7695

Corewell Health Beaumont Troy Hospital
Troy, Michigan 48085
Contact:
Site Public Contact
248-551-7695

Hematology Oncology Consultants PC-Troy
Troy, Michigan 48098
Contact:
Site Public Contact
248-551-7695

Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Cambridge Medical Center
Cambridge, Minnesota 55008
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Southdale Hospital
Edina, Minnesota 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Health Partners Inc
Minneapolis, Minnesota 55454
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
Contact:
Site Public Contact
612-624-2620

Monticello Cancer Center
Monticello, Minnesota 55362
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

New Ulm Medical Center
New Ulm, Minnesota 56073
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Northland Medical Center
Princeton, Minnesota 55371
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Site Public Contact
855-776-0015

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul, Minnesota 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Lakeview Hospital
Stillwater, Minnesota 55082
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Ridgeview Medical Center
Waconia, Minnesota 55387
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Rice Memorial Hospital
Willmar, Minnesota 56201
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Lakes Medical Center
Wyoming, Minnesota 55092
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
Contact:
Site Public Contact
406-327-3118
amy.hanneman@providence.org

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-334-4773

Nebraska Methodist Hospital
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5144

Oncology Associates PC
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5860
info@oa-oc.com

Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Contact:
Site Public Contact
402-559-5600

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Site Public Contact
402-559-6941
unmcrsa@unmc.edu

Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-693-6870
jamador@wccenter.com

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592

Cooper Hospital University Medical Center
Camden, New Jersey 08103
Contact:
Site Public Contact
856-325-6757

Jersey City Medical Center
Jersey City, New Jersey 07302
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Saint Barnabas Medical Center
Livingston, New Jersey 07039
Contact:
Site Public Contact
973-322-2934
joanne.loeb@rwjbh.org

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592

Morristown Medical Center
Morristown, New Jersey 07960
Contact:
Site Public Contact
973-971-5900

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356

Rutgers New Jersey Medical School
Newark, New Jersey 07101
Contact:
Site Public Contact
732-235-7356

Capital Health Medical Center-Hopewell
Pennington, New Jersey 08534
Contact:
Site Public Contact
609-394-4130
clinicaltrials@capitalhealth.org

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Contact:
Site Public Contact
908-685-2481
Siby.Varughese@rwjbh.org

Overlook Hospital
Summit, New Jersey 07902
Contact:
Site Public Contact
908-522-2043

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Women's Cancer Care Associates LLC
Albany, New York 12208
Contact:
Site Public Contact
518-458-1390
jbarlin@womenscancercareassociates.com

Northwell Health Imbert Cancer Center
Bay Shore, New York 11706
Contact:
Site Public Contact
516-734-8896

South Shore University Hospital
Bay Shore, New York 11706
Contact:
Site Public Contact
516-734-8896

Island Gynecologic Oncology
Brightwaters, New York 11718
Contact:
Site Public Contact
516-734-8896

Memorial Sloan Kettering Commack
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

Huntington Hospital
Huntington, New York 11743
Contact:
Site Public Contact
516-734-8896

Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896

North Shore University Hospital
Manhasset, New York 11030
Contact:
Site Public Contact
516-734-8896

NYU Langone Hospital - Long Island
Mineola, New York 11501
Contact:
Site Public Contact
212-263-4432
cancertrials@nyulangone.org

Northern Westchester Hospital
Mount Kisco, New York 10549
Contact:
Site Public Contact
914-666-1366
AMellor@northwell.edu

Long Island Jewish Medical Center
New Hyde Park, New York 11040
Contact:
Site Public Contact
516-734-8896

Northwell Health Physician Partners
New Hyde Park, New York 11042
Contact:
Site Public Contact
516-734-8896

Mount Sinai Chelsea
New York, New York 10011
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
Contact:
Site Public Contact
CancerTrials@nyulangone.org

Mount Sinai West
New York, New York 10019
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Lenox Hill Hospital
New York, New York 10021
Contact:
Site Public Contact
516-734-8896

Mount Sinai Hospital
New York, New York 10029
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
Contact:
Site Public Contact
212-342-5162
cancerclinicaltrials@cumc.columbia.edu

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Site Public Contact
212-639-7592

NYP/Weill Cornell Medical Center
New York, New York 10065
Contact:
Site Public Contact
212-746-1848

Vassar Brothers Medical Center
Poughkeepsie, New York 12601
Contact:
Site Public Contact
845-483-6483

Northwell Physician Partners at Rego Park
Rego Park, New York 11374
Contact:
Site Public Contact
516-734-8896

Queens Cancer Center
Rego Park, New York 11374
Contact:
Site Public Contact
718-312-3446

Highland Hospital
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Phelps Memorial Hospital Center
Sleepy Hollow, New York 10591
Contact:
Site Public Contact
914-366-1600

Stony Brook University Medical Center
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215

State University of New York Upstate Medical University
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592

Duke Cancer Institute Cary
Cary, North Carolina 27518
Contact:
Site Public Contact
919-781-7070

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853

Duke Women's Cancer Care Raleigh
Raleigh, North Carolina 27607
Contact:
Site Public Contact
919-785-4878

Duke Raleigh Hospital
Raleigh, North Carolina 27609
Contact:
Site Public Contact
919-862-5400

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Bethesda North Hospital
Cincinnati, Ohio 45242
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Cincinnati, Ohio 45247
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Cincinnati, Ohio 45255
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Site Public Contact
216-778-7559
ababal@metrohealth.org

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio 43606
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402

Saint Charles Health System
Bend, Oregon 97701
Contact:
Site Public Contact
541-706-2909
nosall@stcharleshealthcare.org

Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Bay Area Hospital
Coos Bay, Oregon 97420
Contact:
Site Public Contact
541-269-8392
cherie.cox@bayareahospital.org

Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Contact:
Site Public Contact
800-220-4937
cancer@lhs.org

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Site Public Contact
503-494-1080
trials@ohsu.edu

Saint Charles Health System-Redmond
Redmond, Oregon 97756
Contact:
Site Public Contact
541-706-2909

Legacy Meridian Park Hospital
Tualatin, Oregon 97062
Contact:
Site Public Contact
503-413-1742

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Contact:
Site Public Contact
412-359-3043
ddefazio@wpahs.org

Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania 17601
Contact:
Site Public Contact
717-544-0511
nctn@pennmedicine.upenn.edu

Lancaster General Hospital
Lancaster, Pennsylvania 17602
Contact:
Site Public Contact
717-544-5511
nctn@pennmedicine.upenn.edu

Forbes Hospital
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-858-7746

Allegheny Valley Hospital
Natrona Heights, Pennsylvania 15065
Contact:
Site Public Contact
Dawnmarie.DeFazio@ahn.org

University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
Contact:
Site Public Contact
855-216-0098
PennCancerTrials@careboxhealth.com

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Mark S. Shahin
Mark.Shahin@jefferson.edu

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Site Public Contact
215-728-4790

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Contact:
Site Public Contact
877-284-2000

West Penn Hospital
Pittsburgh, Pennsylvania 15224
Contact:
Site Public Contact
412-578-5000

Chester County Hospital
West Chester, Pennsylvania 19380
Contact:
Site Public Contact
610-431-5044
carolann.hoppes@pennmedicine.upenn.edu

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Contact:
Site Public Contact
Dawnmarie.DeFazio@ahn.org

Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Women and Infants Hospital
Providence, Rhode Island 02905
Contact:
Site Public Contact
401-274-1122

Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina 29910
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Gibbs Cancer Center-Gaffney
Gaffney, South Carolina 29341
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251

Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251

Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
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864-241-6251

Spartanburg Medical Center
Spartanburg, South Carolina 29303
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864-560-6104
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MGC Hematology Oncology-Union
Union, South Carolina 29379
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864-560-6104
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
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605-312-3320
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
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Vanderbilt-Ingram Cancer Center at Franklin
Franklin, Tennessee 37067
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800-811-8480

Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee 37067
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800-811-8480

Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
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800-811-8480

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
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800-811-8480

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
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713-798-1354
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Ben Taub General Hospital
Houston, Texas 77030
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University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
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University of Utah Sugarhouse Health Center
Salt Lake City, Utah 84106
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888-424-2100
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
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University of Virginia Cancer Center
Charlottesville, Virginia 22908
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Inova Schar Cancer Institute
Fairfax, Virginia 22031
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Fairfax, Virginia 22033
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Henrico Doctor's Hospital
Richmond, Virginia 23229
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VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
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Carilion Clinic Gynecological Oncology
Roanoke, Virginia 24016
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Providence Regional Cancer System-Aberdeen
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Edmonds, Washington 98026
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Mount Vernon, Washington 98274
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FHCC South Lake Union
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University of Washington Medical Center - Northwest
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PeaceHealth United General Medical Center
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Providence Regional Cancer System-Shelton
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Legacy Salmon Creek Hospital
Vancouver, Washington 98686
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503-413-2150

Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
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509-897-5993
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Providence Regional Cancer System-Yelm
Yelm, Washington 98597
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West Virginia University Charleston Division
Charleston, West Virginia 25304
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West Virginia University Healthcare
Morgantown, West Virginia 26506
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Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
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Aurora Saint Luke's South Shore
Cudahy, Wisconsin 53110
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Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
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Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
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Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
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920-433-8889
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Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
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414-302-2304
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Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
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800-622-8922
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Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
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414-302-2304
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Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
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800-782-8581
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Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
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414-302-2304
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Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
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414-302-2304
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Medical College of Wisconsin
Milwaukee, Wisconsin 53226
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414-805-3666

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
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414-302-2304
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ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
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research.institute@phci.org

Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
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952-993-1517
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ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
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262-928-7878

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
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414-302-2304
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Aurora Cancer Care-Racine
Racine, Wisconsin 53406
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414-302-2304
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Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
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414-302-2304
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Aurora Medical Center in Summit
Summit, Wisconsin 53066
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414-302-2304
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Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
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414-302-2304
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ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
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262-928-7632

UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
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262-928-5539
Chanda.miller@phci.org

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
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414-302-2304
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Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
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414-302-2304
ncorp@aurora.org

More Details

NCT ID
NCT04251052
Status
Recruiting
Sponsor
NRG Oncology

Detailed Description

PRIMARY OBJECTIVE: I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations. SECONDARY OBJECTIVES: I. To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to pre-menopausal patients in the BSO arm. II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist [MSCL]) and sexual dysfunction (Female Sexual Function Index [FSFI]) in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients. III. To determine if health-related QOL (FACT) is negatively impacted by cancer distress (Impact of Event Scale [IES]) in individuals who have undergone BLS, in comparison to BSO patients. IV. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice. V. To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. EXPLORATORY OBJECTIVES: I. Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items (pre-menopausal patients). II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction. III. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice. TRANSLATIONAL RESEARCH OBJECTIVE: I. To bank tissue and blood biospecimens for future research. OUTLINE: Patients choose between 1 of 2 groups. GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. GROUP II: Patients undergo bilateral salpingo-oophorectomy. Patients in both groups also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial. After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.