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 Sex
- 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
Arm | Description | Assigned 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. |
|
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. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233
Anchorage 5879400, Alaska 5879092 98508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Tucson 5318313, Arizona 5551752 85719
Tucson 5318313, Arizona 5551752 85719
Little Rock 4119403, Arkansas 4099753 72205
Site Public Contact
501-686-8274
Antioch 5324200, California 5332921 94531
Beverly Hills 5328041, California 5332921 90211
Buena Park 5331575, California 5332921 90621
Site Public Contact
714-522-0908
Burbank 5331835, California 5332921 91505
Duarte 5344147, California 5332921 91010
Dublin 5344157, California 5332921 94568
Site Public Contact
877-642-4691
Fremont 5350734, California 5332921 94538
Fresno 5350937, California 5332921 93720
Fresno 5350937, California 5332921 93720
Huntington Beach 5358705, California 5332921 92648
Site Public Contact
626-256-4673
Huntington Beach 5358705, California 5332921 92648
Irvine 5359777, California 5332921 92618
Site Public Contact
877-467-3411
Irvine 5359777, California 5332921 92618
Lancaster 5364940, California 5332921 93534
Los Angeles 5368361, California 5332921 90020
Site Public Contact
213-388-0908
Los Angeles 5368361, California 5332921 90027
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Site Public Contact
323-865-0451
Los Angeles 5368361, California 5332921 90048
Site Public Contact
310-423-8965
Los Angeles 5368361, California 5332921 90095
Site Public Contact
888-798-0719
Modesto 5373900, California 5332921 95356
Napa 5376095, California 5332921 94558
Site Public Contact
707-521-3830
Newport Beach 5376890, California 5332921 92663
Site Public Contact
323-865-0451
Oakland 5378538, California 5332921 94611
Oakland 5378538, California 5332921 94611
Panorama City 5380932, California 5332921 91402
Pasadena 5381396, California 5332921 91105
Site Public Contact
626-535-2420
Pasadena 5381396, California 5332921 91105
Site Public Contact
323-865-0451
Rancho Cordova 5385941, California 5332921 95670
Redwood City 5386834, California 5332921 94063
Site Public Contact
877-642-4691
Redwood City 5386834, California 5332921 94063
Richmond 5387428, California 5332921 94801
Riverside 5387877, California 5332921 92505
Rohnert Park 5388564, California 5332921 94928
Roseville 5388881, California 5332921 95661
Roseville 5388881, California 5332921 95678
Sacramento 5389489, California 5332921 95814
Sacramento 5389489, California 5332921 95817
Site Public Contact
916-734-3089
Sacramento 5389489, California 5332921 95823
Sacramento 5389489, California 5332921 95823
San Francisco 5391959, California 5332921 94115
San Francisco 5391959, California 5332921 94158
San Jose 5392171, California 5332921 95119
San Leandro 5392263, California 5332921 94577
San Rafael 5392567, California 5332921 94903
Santa Clara 5393015, California 5332921 95051
Santa Rosa 5393287, California 5332921 95403
Santa Rosa 5393287, California 5332921 95403
Site Public Contact
707-521-3830
Santa Rosa 5393287, California 5332921 95405
Site Public Contact
707-521-3830
South Pasadena 5397717, California 5332921 91030
South San Francisco 5397765, California 5332921 94080
South San Francisco 5397765, California 5332921 94080
Stockton 5399020, California 5332921 95210
Torrance 5403022, California 5332921 90503
Site Public Contact
877-467-3411
Torrance 5403022, California 5332921 90505
Upland 5404915, California 5332921 91786
Vacaville 5405228, California 5332921 95688
Vallejo 5405380, California 5332921 94589
Walnut Creek 5406990, California 5332921 94596
Aurora 5412347, Colorado 5417618 80045
Site Public Contact
720-848-0650
Colorado Springs 5417598, Colorado 5417618 80909
Site Public Contact
719-365-2406
Colorado Springs 5417598, Colorado 5417618 80920
Site Public Contact
719-364-6700
Highlands Ranch 5425043, Colorado 5417618 80129
Site Public Contact
720-848-0650
Danbury 4832353, Connecticut 4831725 06810
Site Public Contact
203-739-8074
Greenwich 4835395, Connecticut 4831725 06830
Hartford 4835797, Connecticut 4831725 06102
Site Public Contact
860-545-5363
New Britain 4839292, Connecticut 4831725 06050
Site Public Contact
860-224-5660
New Haven 4839366, Connecticut 4831725 06510
New Haven 4839366, Connecticut 4831725 06520
Norwalk 4839822, Connecticut 4831725 06856
Waterford 8480031, Connecticut 4831725 06385
Newark 4143861, Delaware 4142224 19713
Newark 4143861, Delaware 4142224 19718
Wilmington 4145381, Delaware 4142224 19801
Washington D.C. 4140963, District of Columbia 4138106 20037
Site Public Contact
202-741-2981
Aventura 4146429, Florida 4155751 33180
Site Public Contact
954-461-2180
Bradenton 4148708, Florida 4155751 34205
Coral Gables 4151871, Florida 4155751 33146
Site Public Contact
305-243-2647
Deerfield Beach 4153071, Florida 4155751 33442
Site Public Contact
305-243-2647
Doral 4153471, Florida 4155751 33166
Fort Myers 4155995, Florida 4155751 33905
Fort Myers 4155995, Florida 4155751 33905
Gainesville 4156404, Florida 4155751 32610
Miami 4164138, Florida 4155751 33136
Site Public Contact
305-243-3975
Miami 4164138, Florida 4155751 33136
Site Public Contact
305-243-2647
Miami 4164138, Florida 4155751 33176
Site Public Contact
305-243-2647
N. Venice, Florida 4155751 34275
Site Public Contact
941-261-9000
Plantation 4168782, Florida 4155751 33324
Site Public Contact
305-243-2647
Sarasota 4172131, Florida 4155751 34232
Sarasota 4172131, Florida 4155751 34232
Site Public Contact
941-200-1125
Sarasota 4172131, Florida 4155751 34236
Site Public Contact
941-957-1000
Sarasota 4172131, Florida 4155751 34239
Site Public Contact
941-917-5400
Sarasota 4172131, Florida 4155751 34239
Site Public Contact
941-917-8383
Sarasota 4172131, Florida 4155751 34239
Site Public Contact
941-917-2225
Sarasota 4172131, Florida 4155751 34243
Site Public Contact
941-917-6519
Venice 4176380, Florida 4155751 34275
Venice 4176380, Florida 4155751 34285
Atlanta 4180439, Georgia 4197000 30303
Site Public Contact
404-778-1868
Atlanta 4180439, Georgia 4197000 30308
Site Public Contact
888-946-7447
Atlanta 4180439, Georgia 4197000 30322
Site Public Contact
404-778-1868
Atlanta 4180439, Georgia 4197000 30342
Site Public Contact
404-851-7115
Atlanta 4180439, Georgia 4197000 30342
Augusta 4180531, Georgia 4197000 30912
Savannah 4221552, Georgia 4197000 31405
Honolulu 5856195, Hawaii 5855797 96813
Honolulu 5856195, Hawaii 5855797 96813
Site Public Contact
808-532-0315
Honolulu 5856195, Hawaii 5855797 96813
Site Public Contact
808-545-8548
Honolulu 5856195, Hawaii 5855797 96813
Site Public Contact
808-522-4333
Honolulu 5856195, Hawaii 5855797 96813
Site Public Contact
808-586-2979
Honolulu 5856195, Hawaii 5855797 96817
Site Public Contact
808-547-9816
Honolulu 5856195, Hawaii 5855797 96817
Site Public Contact
808-531-8521
Honolulu 5856195, Hawaii 5855797 96817
Site Public Contact
808-547-6881
Honolulu 5856195, Hawaii 5855797 96819
Honolulu 5856195, Hawaii 5855797 96826
Site Public Contact
808-983-6090
Lihue 5850248, Hawaii 5855797 96766
Site Public Contact
808-535-7960
‘Aiea 5856430, Hawaii 5855797 96701
‘Aiea 5856430, Hawaii 5855797 96701
Site Public Contact
808-486-6000
‘Aiea 5856430, Hawaii 5855797 96701
Site Public Contact
808-487-7447
‘Aiea 5856430, Hawaii 5855797 96701
Site Public Contact
808-678-9000
‘Ewa Beach 5855051, Hawaii 5855797 96706
Boise 5586437, Idaho 5596512 83712
Fruitland 5593708, Idaho 5596512 83619
Meridian 5600685, Idaho 5596512 83642
Nampa 5601933, Idaho 5596512 83687
Twin Falls 5610810, Idaho 5596512 83301
Aurora 4883817, Illinois 4896861 60504
Aurora 4883817, Illinois 4896861 60506
Barrington 4884116, Illinois 4896861 60010
Site Public Contact
847-842-4847
Bloomington 4885164, Illinois 4896861 61704
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60637
Chicago 4887398, Illinois 4896861 60657
Site Public Contact
773-296-5360
Crystal Lake 4889229, Illinois 4896861 60014
Danville 4889426, Illinois 4896861 61832
DeKalb 4889553, Illinois 4896861 60115
Downers Grove 4890119, Illinois 4896861 60515
Effingham 4237727, Illinois 4896861 62401
Elgin 4890864, Illinois 4896861 60123
Site Public Contact
847-429-2907
Elmhurst 4891010, Illinois 4896861 60126
Evanston 4891382, Illinois 4896861 60201
Site Public Contact
847-570-2109
Geneva 4893591, Illinois 4896861 60134
Glenview 4893886, Illinois 4896861 60026
Site Public Contact
847-570-2109
Hazel Crest 4895416, Illinois 4896861 60429
Site Public Contact
708-799-9995
Highland Park 4895876, Illinois 4896861 60035
Site Public Contact
847-570-2109
Lake Forest 4899012, Illinois 4896861 60045
Libertyville 4899739, Illinois 4896861 60048
Libertyville 4899739, Illinois 4896861 60048
Mattoon 4244099, Illinois 4896861 61938
Naperville 4903279, Illinois 4896861 60540
Site Public Contact
630-646-6075
New Lenox 4903535, Illinois 4896861 60451
Normal 4903780, Illinois 4896861 61761
Normal 4903780, Illinois 4896861 61761
Oak Lawn 4904365, Illinois 4896861 60453-2699
Site Public Contact
800-323-8622
Oak Park 4904381, Illinois 4896861 60304
Orland Park 4904937, Illinois 4896861 60462
Park Ridge 4905367, Illinois 4896861 60068
Site Public Contact
847-384-3621
Plainfield 4906125, Illinois 4896861 60585
Urbana 4914570, Illinois 4896861 61801
Urbana 4914570, Illinois 4896861 61801
Warrenville 4915525, Illinois 4896861 60555
Yorkville 4917298, Illinois 4896861 60560
Carmel 4255466, Indiana 4921868 46032
Crown Point 4919451, Indiana 4921868 46307
Goshen 4920808, Indiana 4921868 46526
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46260
Council Bluffs 4852832, Iowa 4862182 51503
Site Public Contact
712-322-4136
Council Bluffs 4852832, Iowa 4862182 51503
Council Bluffs 4852832, Iowa 4862182 51503
Iowa City 4862034, Iowa 4862182 52242
Site Public Contact
800-237-1225
Fairway 4271358, Kansas 4273857 66205
Kansas City 4273837, Kansas 4273857 66160
Overland Park 4276873, Kansas 4273857 66211
Westwood 4281639, Kansas 4273857 66205
Corbin 4288656, Kentucky 6254925 40701
Site Public Contact
859-523-1934
Edgewood 4290873, Kentucky 6254925 41017
Lexington 4297983, Kentucky 6254925 40503
Site Public Contact
859-260-6425
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40207
Louisville 4299276, Kentucky 6254925 40207
Site Public Contact
502-629-3465
Paducah 4048662, Kentucky 6254925 42003
Site Public Contact
270-575-2928
Marrero 4332628, Louisiana 4331987 70072
New Orleans 4335045, Louisiana 4331987 70112
New Orleans 4335045, Louisiana 4331987 70112
Shreveport 4341513, Louisiana 4331987 71103
Portland 4975802, Maine 4971068 04102
Scarborough 4977882, Maine 4971068 04074
Bethesda 4348599, Maryland 4361885 20889-5600
Site Public Contact
301-319-2100
Elkton 4354234, Maryland 4361885 21921
Springfield 4951788, Massachusetts 6254926 01199
Dearborn 4990510, Michigan 5001836 48124
Site Public Contact
248-551-7695
Detroit 4990729, Michigan 5001836 48201
Farmington Hills 4992523, Michigan 5001836 48334
Farmington Hills 4992523, Michigan 5001836 48336
Site Public Contact
248-551-7695
Flint 4992982, Michigan 5001836 48532
Grand Rapids 4994358, Michigan 5001836 49503
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49048
Muskegon 5003132, Michigan 5001836 49444
Royal Oak 5007804, Michigan 5001836 48067
Site Public Contact
248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
Site Public Contact
248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
Site Public Contact
248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
Site Public Contact
248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
Site Public Contact
248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
Site Public Contact
248-551-7695
Sterling Heights 5011148, Michigan 5001836 48312
Site Public Contact
248-551-7695
Troy 5012639, Michigan 5001836 48084
Site Public Contact
248-551-7695
Troy 5012639, Michigan 5001836 48085
Site Public Contact
248-551-7695
Troy 5012639, Michigan 5001836 48098
Site Public Contact
248-551-7695
Burnsville 5019767, Minnesota 5037779 55337
Cambridge 5020068, Minnesota 5037779 55008
Coon Rapids 5022025, Minnesota 5037779 55433
Edina 5025264, Minnesota 5037779 55435
Maple Grove 5036493, Minnesota 5037779 55369
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55415
Minneapolis 5037649, Minnesota 5037779 55454
Minneapolis 5037649, Minnesota 5037779 55455
Site Public Contact
612-624-2620
Monticello 5038045, Minnesota 5037779 55362
New Ulm 5039173, Minnesota 5037779 56073
Princeton 5042360, Minnesota 5037779 55371
Robbinsdale 5043439, Minnesota 5037779 55422
Rochester 5043473, Minnesota 5037779 55905
Site Public Contact
855-776-0015
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Shakopee 5046997, Minnesota 5037779 55379
Stillwater 5048814, Minnesota 5037779 55082
Waconia 5051640, Minnesota 5037779 55387
Willmar 5052916, Minnesota 5037779 56201
Woodbury 5053358, Minnesota 5037779 55125
Wyoming 5053526, Minnesota 5037779 55092
North Kansas City 4400860, Missouri 4398678 64116
Springfield 4409896, Missouri 4398678 65804
Site Public Contact
417-269-4520
Springfield 4409896, Missouri 4398678 65807
Site Public Contact
417-269-4520
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63131
Site Public Contact
314-996-5569
Billings 5640350, Montana 5667009 59101
Bozeman 5641727, Montana 5667009 59715
Missoula 5666639, Montana 5667009 59802
Omaha 5074472, Nebraska 5073708 68114
Site Public Contact
402-334-4773
Omaha 5074472, Nebraska 5073708 68114
Site Public Contact
402-354-5144
Omaha 5074472, Nebraska 5073708 68114
Omaha 5074472, Nebraska 5073708 68118
Site Public Contact
402-559-5600
Omaha 5074472, Nebraska 5073708 68198
Las Vegas 5506956, Nevada 5509151 89106
Site Public Contact
702-851-4672
Basking Ridge 5095409, New Jersey 5101760 07920
Site Public Contact
212-639-7592
Camden 4501018, New Jersey 5101760 08103
Site Public Contact
856-325-6757
Jersey City 5099836, New Jersey 5101760 07302
Livingston 5100572, New Jersey 5101760 07039
Middletown 5101170, New Jersey 5101760 07748
Site Public Contact
212-639-7592
Montvale 5101361, New Jersey 5101760 07645
Site Public Contact
212-639-7592
Morristown 5101427, New Jersey 5101760 07960
Site Public Contact
973-971-5900
Mount Holly 4503134, New Jersey 5101760 08060
Site Public Contact
609-914-6762
New Brunswick 5101717, New Jersey 5101760 08903
Site Public Contact
732-235-7356
Newark 5101798, New Jersey 5101760 07101
Site Public Contact
732-235-7356
Pennington 5102535, New Jersey 5101760 08534
Somerville 5104774, New Jersey 5101760 08876
Summit 5105127, New Jersey 5101760 07902
Site Public Contact
908-522-2043
Voorhees Township 5105860, New Jersey 5101760 08043
Albuquerque 5454711, New Mexico 5481136 87106
Rio Rancho 5487811, New Mexico 5481136 87124
Albany 5106834, New York 5128638 12208
Bay Shore 5108169, New York 5128638 11706
Site Public Contact
516-734-8896
Bay Shore 5108169, New York 5128638 11706
Site Public Contact
516-734-8896
Brightwaters 5110168, New York 5128638 11718
Site Public Contact
516-734-8896
Commack 5113412, New York 5128638 11725
Site Public Contact
212-639-7592
Flushing 5117472, New York 5128638 11354
Harrison 5120095, New York 5128638 10604
Site Public Contact
212-639-7592
Huntington 5121636, New York 5128638 11743
Site Public Contact
516-734-8896
Lake Success 5123853, New York 5128638 11042
Site Public Contact
516-734-8896
Manhasset 5125766, New York 5128638 11030
Site Public Contact
516-734-8896
Mineola 5127134, New York 5128638 11501
Mount Kisco 5127744, New York 5128638 10549
New Hyde Park 5128514, New York 5128638 11040
Site Public Contact
516-734-8896
New Hyde Park 5128514, New York 5128638 11042
Site Public Contact
516-734-8896
New York 5128581, New York 5128638 10011
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10019
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10065
Site Public Contact
212-639-7592
New York 5128581, New York 5128638 10065
Site Public Contact
212-746-1848
New York 5128581, New York 5128638 10075
Site Public Contact
516-734-8896
Poughkeepsie 5132143, New York 5128638 12601
Site Public Contact
845-483-6483
Rego Park 5133640, New York 5128638 11374
Site Public Contact
516-734-8896
Rego Park 5133640, New York 5128638 11374
Site Public Contact
718-312-3446
Rochester 5134086, New York 5128638 14620
Site Public Contact
585-341-8113
Rochester 5134086, New York 5128638 14642
Site Public Contact
585-275-5830
Sleepy Hollow 5138371, New York 5128638 10591
Site Public Contact
914-366-1600
Stony Brook 5139865, New York 5128638 11794
Site Public Contact
800-862-2215
Syracuse 5140405, New York 5128638 13210
Site Public Contact
315-464-5476
Uniondale 5141927, New York 5128638 11553
Site Public Contact
212-639-7592
Cary 4459467, North Carolina 4482348 27518
Chapel Hill 4460162, North Carolina 4482348 27599
Durham 4464368, North Carolina 4482348 27710
Site Public Contact
888-275-3853
Raleigh 4487042, North Carolina 4482348 27607
Site Public Contact
919-785-4878
Raleigh 4487042, North Carolina 4482348 27609
Winston-Salem 4499612, North Carolina 4482348 27157
Site Public Contact
336-713-6771
Akron 5145476, Ohio 5165418 44307
Athens 4505542, Ohio 5165418 45701
Centerville 4508204, Ohio 5165418 45459
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45220
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45247
Cincinnati 4508722, Ohio 5165418 45255
Cleveland 5150529, Ohio 5165418 44109
Cleveland 5150529, Ohio 5165418 44111
Cleveland 5150529, Ohio 5165418 44195
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43214
Columbus 4509177, Ohio 5165418 43214
Columbus 4509177, Ohio 5165418 43215
Columbus 4509177, Ohio 5165418 43228
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45415
Delaware 5151891, Ohio 5165418 43015
Delaware 5151891, Ohio 5165418 43015
Dublin 5152333, Ohio 5165418 43016
Dublin 5152333, Ohio 5165418 43016
Franklin 4512203, Ohio 5165418 45005-1066
Greenville 5156493, Ohio 5165418 45331
Site Public Contact
937-569-7515
Mansfield 5161723, Ohio 5165418 44903
Marion 5161902, Ohio 5165418 43302
Mayfield Heights 5162188, Ohio 5165418 44124
Pickerington 4521209, Ohio 5165418 43147
Sylvania 5173572, Ohio 5165418 43560
Toledo 5174035, Ohio 5165418 43606
Troy 5174358, Ohio 5165418 45373
West Chester 4520522, Ohio 5165418 45069
Westerville 5176472, Ohio 5165418 43082
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73120
Site Public Contact
405-752-3402
Bend 5713587, Oregon 5744337 97701
Clackamas 5719308, Oregon 5744337 97015
Coos Bay 5720495, Oregon 5744337 97420
Newberg 5742726, Oregon 5744337 97132
Oregon City 5744253, Oregon 5744337 97045
Portland 5746545, Oregon 5744337 97210
Portland 5746545, Oregon 5744337 97213
Portland 5746545, Oregon 5744337 97225
Portland 5746545, Oregon 5744337 97239
Redmond 5747882, Oregon 5744337 97756
Site Public Contact
541-706-2909
Tualatin 5757506, Oregon 5744337 97062
Site Public Contact
503-413-1742
Chadds Ford 4557084, Pennsylvania 6254927 19317
Hershey 5193342, Pennsylvania 6254927 17033-0850
Jefferson Hills 5195297, Pennsylvania 6254927 15025
Lancaster 5197079, Pennsylvania 6254927 17601
Lancaster 5197079, Pennsylvania 6254927 17602
Monroeville 5201734, Pennsylvania 6254927 15146
Site Public Contact
412-858-7746
Natrona Heights 5202903, Pennsylvania 6254927 15065
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19111
Site Public Contact
215-728-4790
Pittsburgh 5206379, Pennsylvania 6254927 15212
Site Public Contact
877-284-2000
Pittsburgh 5206379, Pennsylvania 6254927 15213
Site Public Contact
412-647-2811
Pittsburgh 5206379, Pennsylvania 6254927 15224
Site Public Contact
412-578-5000
Pittsburgh 5206379, Pennsylvania 6254927 15232
Site Public Contact
412-647-8073
West Chester 4562144, Pennsylvania 6254927 19380
Wexford 5219062, Pennsylvania 6254927 15090
Providence 5224151, Rhode Island 5224323 02905
Site Public Contact
401-274-1122
Bluffton 4571722, South Carolina 4597040 29910
Charleston 4574324, South Carolina 4597040 29425
Gaffney 4579418, South Carolina 4597040 29341
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greer 4580599, South Carolina 4597040 29651
Seneca 4595346, South Carolina 4597040 29672
Site Public Contact
864-241-6251
Spartanburg 4597200, South Carolina 4597040 29303
Union 4599214, South Carolina 4597040 29379
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Franklin 4623560, Tennessee 4662168 37067
Site Public Contact
800-811-8480
Franklin 4623560, Tennessee 4662168 37067
Site Public Contact
800-811-8480
Nashville 4644585, Tennessee 4662168 37204
Site Public Contact
800-811-8480
Nashville 4644585, Tennessee 4662168 37232
Site Public Contact
800-811-8480
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Site Public Contact
713-873-2000
Houston 4699066, Texas 4736286 77030
Site Public Contact
713-792-3245
Salt Lake City 5780993, Utah 5549030 84106
Salt Lake City 5780993, Utah 5549030 84112
Charlottesville 4752031, Virginia 6254928 22908
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 22033
Falls Church 4758390, Virginia 6254928 22042
Richmond 4781708, Virginia 6254928 23229
Richmond 4781708, Virginia 6254928 23235
Richmond 4781708, Virginia 6254928 23298
Roanoke 4782167, Virginia 6254928 24033
Site Public Contact
540-985-8510
Aberdeen 5785243, Washington 5815135 98520
Bellingham 5786899, Washington 5815135 98225
Site Public Contact
360-788-8223
Centralia 5789683, Washington 5815135 98531
Edmonds 5793427, Washington 5815135 98026
Everett 5793933, Washington 5815135 98201
Issaquah 5798487, Washington 5815135 98029
Kennewick 5799610, Washington 5815135 99336
Lacey 5800112, Washington 5815135 98503
Longview 5801617, Washington 5815135 98632
Mount Vernon 5804127, Washington 5815135 98274
Seattle 5809844, Washington 5815135 98107
Seattle 5809844, Washington 5815135 98109
Site Public Contact
800-804-8824
Seattle 5809844, Washington 5815135 98122-5711
Seattle 5809844, Washington 5815135 98122
Seattle 5809844, Washington 5815135 98133
Site Public Contact
800-804-8824
Seattle 5809844, Washington 5815135 98195
Site Public Contact
800-804-8824
Sedro-Woolley 5809902, Washington 5815135 98284
Vancouver 5814616, Washington 5815135 98686
Site Public Contact
503-413-2150
Walla Walla 5814916, Washington 5815135 99362
Bridgeport 4800081, West Virginia 4826850 26330
Charleston 4801859, West Virginia 4826850 25304
Site Public Contact
304-388-9944
Martinsburg 4813878, West Virginia 4826850 25401
Morgantown 4815352, West Virginia 4826850 26506
Parkersburg 4817641, West Virginia 4826850 26101
Princeton 4819079, West Virginia 4826850 24740
Site Public Contact
304-487-7515
Wheeling 5280854, West Virginia 4826850 26003
Site Public Contact
304-243-6442
Burlington 5247214, Wisconsin 5279468 53105
Cudahy 5249871, Wisconsin 5279468 53110
Germantown 5254218, Wisconsin 5279468 53022
Grafton 5254739, Wisconsin 5279468 53024
Green Bay 5254962, Wisconsin 5279468 54301
Green Bay 5254962, Wisconsin 5279468 54311
Kenosha 5258393, Wisconsin 5279468 53142
Madison 5261457, Wisconsin 5279468 53718
Madison 5261457, Wisconsin 5279468 53792
Marinette 5261852, Wisconsin 5279468 54143
Marshfield 5261969, Wisconsin 5279468 54449
Milwaukee 5263045, Wisconsin 5279468 53209
Milwaukee 5263045, Wisconsin 5279468 53215
Milwaukee 5263045, Wisconsin 5279468 53226
Site Public Contact
414-805-3666
Milwaukee 5263045, Wisconsin 5279468 53233
New Richmond 5264475, Wisconsin 5279468 54017
Oshkosh 5265838, Wisconsin 5279468 54904
Racine 5268249, Wisconsin 5279468 53406
Sheboygan 5272893, Wisconsin 5279468 53081
Summit, Wisconsin 5279468 53066
Two Rivers 5276609, Wisconsin 5279468 54241
Wauwatosa 5278159, Wisconsin 5279468 53226
West Allis 5278420, Wisconsin 5279468 53227
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.