Purpose

This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

Condition

Eligibility

Eligible Ages
Between 45 Years and 74 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Criteria


Inclusion Criteria:

- Women of childbearing potential must not be known to be pregnant or lactating

- Patients must be scheduled for, or have intent to schedule, a screening mammogram

- Patients must be able to tolerate digital breast tomosynthesis and full-field digital
mammographic imaging required by protocol, to be performed at an American College of
Radiology Imaging Network (ACRIN)-qualified facility

- Patients must be willing and able to provide a written informed consent

- Patients must not have symptoms or signs of benign or malignant breast disease (eg,
nipple discharge, breast lump) warranting a diagnostic rather than a screening
mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are
eligible as long as other criteria are met

- Patients must not have had a screening mammogram within the last 11 months prior to
date of randomization

- Patients must not have previous personal history of breast cancer including ductal
carcinoma in situ

- Patients must not have breast enhancements (e.g., implants or injections)

- ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK

- To be eligible for inclusion in the annual screening regimen one of the following
three conditions must be met in addition to the eligibility criteria above:

- Patients are pre-menopausal; OR

- Post-menopausal aged 45-69 with any of the following three risks factors:

- Dense breasts (BIRADS density categories c-heterogeneously dense or
d-extremely dense), or

- Family history of breast cancer (first degree relative with breast cancer),
or, positive genetic testing for any deleterious genes that indicate an
increased risk for breast cancer, or

- Currently on hormone therapy; OR

- Post-menopausal ages 70-74 with either of the following two risk factors:

- Dense breasts (BIRADS density categories c-heterogeneously dense or
d-extremely dense), or

- Currently on hormone therapy

- Postmenopausal women are defined as those with their last menstrual period more than
12 months prior to study entry; for the purpose of defining menopausal status for
women who have had surgical cessation of their periods, women who no longer have
menses due to hysterectomy and oophorectomy will be considered postmenopausal; women
who no longer have menses due to hysterectomy without oophorectomy will be considered
premenopausal until age 52 and postmenopausal thereafter

- All other postmenopausal women are eligible for inclusion in the biennial screening
regimen

- For those women who cannot be assigned to annual or biennial screening at the time of
study entry and randomization because they are postmenopausal, have no family history
or known deleterious breast cancer mutation, are not on hormone therapy AND have not
had a prior mammogram, breast density will be determined by the radiologist?s
recording of it at the time of interpretation of the first study screening
examination, either DM or TM; for those who are randomized to TM, radiologists will
assign BI-RADS density through review of the DM or synthetic DM portion of the TM
examination; such women cannot be part of the planned stratification by screening
frequency and are expected to represent far less than 1% of the Tomosynthesis
Mammographic Imaging Screening Trial (TMIST) population

- Breast density will be determined by prior mammography reports, when available; all
other risk factors used to determine patient eligibility for annual or biennial
screening will be determined by subject self-report

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized to either Digital Breast Tomography (TM) or Full Field Digital Mammography (DM)
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (digital mammography)
Patients undergo bilateral screening DM with standard CC and MLO views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
  • Procedure: Digital Mammography
    Undergo DM
    Other names:
    • Full Field Digital Mammography
    • FFDM
  • Other: Laboratory Biomarker Analysis
    Correlative studies
    Other names:
    • Biomarker analysis
    • genetic analysis
    • PAM50
Experimental
Arm B (digital tomosynthesis mammography)
Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
  • Procedure: Digital Tomosynthesis Mammography
    Undergo TM
    Other names:
    • DBT
    • Digital Breast Tomosynthesis
    • Digital Tomosynthesis of the Breast
  • Other: Laboratory Biomarker Analysis
    Correlative studies
    Other names:
    • Biomarker analysis
    • genetic analysis
    • PAM50

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

Mobile Infirmary Medical Center
Mobile, Alabama 36607
Contact:
Site Public Contact
251-435-3942

University of Arizona College of Medicine Phoenix
Phoenix, Arizona 85006
Contact:
Site Public Contact
520-780-8241
atvalencia@email.arizona.edu

Valleywise Comprehensive Health Center - Phoenix
Phoenix, Arizona 85008
Contact:
Site Public Contact
602-344-5775

Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
Contact:
Site Public Contact
855-776-0015

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Los Angeles County-USC Medical Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

Zuckerberg San Francisco General Hospital
San Francisco, California 94110
Contact:
Site Public Contact
415-476-4082
Paul.Couey@ucsf.edu

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

The Women's Imaging Center
Denver, Colorado 80209
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
Contact:
Site Public Contact
720-848-0650

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
mhayden@christianacare.org

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Site Public Contact
202-444-2223

University of Florida Health Science Center - Jacksonville
Jacksonville, Florida 32209
Contact:
Site Public Contact
888-254-7581

Northside Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-303-3355
ClinicalTrials@northside.com

Northeast Georgia Medical Center Braselton
Braselton, Georgia 30517
Contact:
Site Public Contact
770-219-8800
cancerpatient.navigator@nghs.com

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
Contact:
Site Public Contact
312-864-5204

Carle on Fairchild
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Carle Hoopeston Regional Health Center
Hoopeston, Illinois 60942
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

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

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

The Community Hospital
Munster, Indiana 46321
Contact:
Site Public Contact
219-836-3349

Women's Diagnostic Center - Munster
Munster, Indiana 46321
Contact:
Site Public Contact
219-934-8869
mnicholson@comhs.org

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

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

Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky 42303
Contact:
Site Public Contact
270-691-8094
vanissa.sorrels@owensborohealth.org

Woman's Hospital
Baton Rouge, Louisiana 70817
Contact:
Site Public Contact
225-215-1353
Clinicalreserach@marybird.com

Tulane University Health Sciences Center
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-988-6121

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

Ochsner LSU Health Saint Mary's Medical Center
Shreveport, Louisiana 71101
Contact:
Site Public Contact
318-813-1404
LPost@lsuhsc.edu

LSU Health Sciences Center at Shreveport
Shreveport, Louisiana 71103
Contact:
Site Public Contact
318-813-1404
LPost@lsuhsc.edu

Kaiser Permanente - Kensington Medical Center
Kensington, Maryland 20895
Contact:
Site Public Contact
301-816-7218

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265

UMass Memorial Medical Center - University Campus
Worcester, Massachusetts 01655
Contact:
Site Public Contact
508-856-3216
cancer.research@umassmed.edu

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

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

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

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

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
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

Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Hennepin County Medical Center
Minneapolis, Minnesota 55415
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

Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Carson Tahoe Regional Medical Center
Carson City, Nevada 89703
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Hunterdon Medical Center
Flemington, New Jersey 08822
Contact:
Site Public Contact
908-237-2330

Saint Peter's University Hospital
New Brunswick, New Jersey 08901
Contact:
Site Public Contact
732-745-8600
kcovert@saintpetersuh.com

Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey 07701
Contact:
Site Public Contact
732-530-2382

Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Contact:
Site Public Contact
505-925-0366
LByatt@nmcca.org

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York 14905
Contact:
Site Public Contact
607-271-7000

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
Contact:
Site Public Contact
212-305-6361
nr2616@cumc.columbia.edu

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

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

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

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

University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina 27278
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

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

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota 58103
Contact:
Site Public Contact
605-312-3320

Aultman Health Foundation
Canton, Ohio 44710
Contact:
Site Public Contact
330-363-7274
ClinicalReserachDept@aultman.com

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

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

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

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

Pennsylvania Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
800-789-7366

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@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

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Contact:
Site Public Contact
412-359-3043
ddefazio@wpahs.org

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Prisma Health Richland Hospital
Columbia, South Carolina 29203
Contact:
Site Public Contact
803-434-3533

Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

MUSC Health East Cooper
Mount Pleasant, South Carolina 29464
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Spartanburg Medical Center
Spartanburg, South Carolina 29303
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Spartanburg Medical Center - Mary Black Campus
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-560-6812

University of Tennessee - Knoxville
Knoxville, Tennessee 37920
Contact:
Site Public Contact
865-544-9773

Baptist Memorial Hospital for Women
Memphis, Tennessee 38120
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
Contact:
Site Public Contact
800-811-8480

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

Memorial Hermann Texas Medical Center
Houston, Texas 77030
Contact:
Site Public Contact
713-792-3245

University Hospital
San Antonio, Texas 78229
Contact:
Site Public Contact
210-358-4176
evelyn.swenson-britt@uhs-sa.com

University of Virginia Cancer Center
Charlottesville, Virginia 22908
Contact:
Site Public Contact
434-243-6303
uvacancertrials@hscmail.mcc.virginia.edu

Sentara Leigh Hospital
Norfolk, Virginia 23502
Contact:
Site Public Contact
757-388-5109
djoverto@sentara.com

Sentara Norfolk General Hospital
Norfolk, Virginia 23507
Contact:
Site Public Contact
757-388-2406

Sentara Princess Anne Hospital
Virginia Beach, Virginia 23456
Contact:
Site Public Contact
757-388-5109
djoverto@sentara.com

Swedish Medical Center-First Hill
Seattle, Washington 98122-4307
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

West Virginia University Healthcare
Morgantown, West Virginia 26506
Contact:
Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu

ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Contact:
Site Public Contact
920-364-3605
ResearchDept@thedacare.org

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
Site Public Contact
608-775-2385
cancerctr@gundersenhealth.org

University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Contact:
Site Public Contact
research.institute@phci.org

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878

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

San Juan City Hospital
San Juan, Puerto Rico 00936
Contact:
Site Public Contact
787-763-1296

More Details

NCT ID
NCT03233191
Status
Recruiting
Sponsor
ECOG-ACRIN Cancer Research Group

Detailed Description

PRIMARY OBJECTIVES: I. To compare the proportions of participants in the tomosynthesis mammography (TM) and digital mammography (DM) study arms experiencing the occurrence of an ?advanced? breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). SECONDARY OBJECTIVES: I. To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms. II. To compare the diagnostic performance of TM and DM, as measured by the area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). III. To compare the recall rates and biopsy rates for TM versus DM, with subset analyses by the same variables as listed in aim II. IV. To compare the rate of interval cancers for TM and DM and to assess the mechanism of diagnosis for these interval cancers with categorization by symptomatic versus (vs) asymptomatic, and how detected: diagnosed via physical examination, mammography, ultrasound (US), magnetic resonance imaging (MRI) or other technologies. V. To examine the correlation between Breast Imaging Reporting and Data System (BIRADS) imaging features and histologic and genetic features, such as invasive ductal and invasive lobular histology, high grade, high stage at diagnosis, and aggressive genetic subtypes. VI. To assess different combinations of TM and synthesized 2 dimensional (2D) or DM in reader studies to assist in determining the optimum balance between diagnostic performance, radiation exposure and technique. VII. To estimate and compare breast-cancer-specific mortality between the two study arms. VIII. To estimate and compare the prevalence of breast cancer subtypes (luminal A, luminal B, HER2+, basal-like) low, medium or high proliferation via PAM50 proliferation signatures, and p53 mutant-like or wild-type-like according to a validated p53 dependent signature in the two arms, overall and stratified on whether cancers were detected through screening or as interval cancers, and whether cancers were invasive or in situ. IX. To classify histologically malignant (true positive cases) and benign lesions (false positive cases) as normal-like or tumor-like using the PAM50 gene expression assay subtype (luminal A, luminal B, HER2, basal-like,), and low, medium, or high proliferation according to PAM50 proliferation signatures, and p53 mutant-like or wild-type-like according to a validated p53-dependent signature. X. To assess the agreement between local and expert study pathologists for all breast lesions (benign and malignant) biopsied during the 4.5 years of screening with TM or DM. XI. To create a blood and buccal cell biobank for future biomarker and genetic testing. XII. To compare health care utilization (including cancer care received) and cost of an episode of breast cancer screening by TM versus DM, overall and within subsets. XIII. To implement a centralized quality control (QC) monitoring program for both 2D digital mammography (DM) and tomosynthesis (TM), which provides rapid feedback on image quality, using quantitative tools, taking advantage of the automated analysis of digital images. XIV. To assess temporal and site-to site variations in image quality, breast radiation dose, and other quality control parameters in TM vs. DM. XV. To refine and implement task-based measures of image quality to assess the effects of technical parameters, including machine type, and detector spatial and contrast resolution on measures of diagnostic accuracy for TM. XVI. To evaluate which QC tests are useful for determination of image quality and those that are predictive of device failure, in order to recommend an optimal QC program for TM. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo bilateral screening DM with standard craniocaudal (CC) and mediolateral oblique (MLO) views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal. ARM B: Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal. After completion of study, patients are followed up for at least 4.5-8 years after study entry.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.