Breast Cancer Clinical Trial

Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer

Summary

This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer. Gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known breast cancer susceptibility gene (BRCA)1/2 mutation carriers.

II. To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening.

III. To compare the cancer rates between these two groups of women. IV. To better characterize the similarities and differences in cancer risk between BRCA mutation-positive families and BRCA mutation-negative/family history-positive families.

V. To develop preliminary estimates of overall and cancer-specific mortality, stratified by mutation status (BRCA1-positive, BRCA2-positive, BRCA1/2-negative).

OUTLINE: This is a multicenter study.

Patients complete the Health Update Questionnaire annually for up to 5 years. The questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Enrolled on GOG-0199

Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer
Completed the Off-Study form (Form Q0-0199 submitted via SEDES)
No patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)

Study is for people with:

Breast Cancer

Estimated Enrollment:

1916

Study ID:

NCT01139957

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 135 Locations for this study

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University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
Gynecologic Oncology Group of Arizona
Phoenix Arizona, 85012, United States
Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain Connecticut, 06050, United States
Yale University
New Haven Connecticut, 06520, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
Florida Gynecologic Oncology
Fort Myers Florida, 33905, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
Women's Cancer Associates
Saint Petersburg Florida, 33701, United States
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston Illinois, 60201, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis Indiana, 46260, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park Kansas, 66213, United States
Kansas City NCI Community Oncology Research Program
Prairie Village Kansas, 66208, United States
Saint Elizabeth Medical Center South
Edgewood Kentucky, 41017, United States
Norton Hospital Pavilion and Medical Campus
Louisville Kentucky, 40202, United States
Maine Medical Center-Bramhall Campus
Portland Maine, 04102, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore Maryland, 21237, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
National Institutes of Health Clinical Center
Bethesda Maryland, 20892, United States
Union Hospital of Cecil County
Elkton Maryland, 21921, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
UMass Memorial Medical Center - Memorial Division
Worcester Massachusetts, 01605, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Bronson Battle Creek
Battle Creek Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids Michigan, 49307, United States
Beaumont Hospital - Dearborn
Dearborn Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint Michigan, 48532, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
Allegiance Health
Jackson Michigan, 49201, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
Mercy Health Mercy Campus
Muskegon Michigan, 49444, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Lake Huron Medical Center
Port Huron Michigan, 48060, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Metro Health Hospital
Wyoming Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
New Ulm Medical Center
New Ulm Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
University of Missouri - Ellis Fischel
Columbia Missouri, 65212, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
North Kansas City Hospital
Kansas City Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City Missouri, 64118, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph Missouri, 64507, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Nebraska Cancer Research Center
Lincoln Nebraska, 68510, United States
Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Nebraska Methodist Hospital
Omaha Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst North Carolina, 28374, United States
Aultman Health Foundation
Canton Ohio, 44710, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati Ohio, 45219, United States
Good Samaritan Hospital - Cincinnati
Cincinnati Ohio, 45220, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Hillcrest Hospital Cancer Center
Mayfield Heights Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa Oklahoma, 74146, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood Pennsylvania, 19096, United States
Women and Infants Hospital
Providence Rhode Island, 02905, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Wilford Hall Medical Center
Lackland Air Force Base Texas, 78236, United States
University of Vermont Medical Center
Burlington Vermont, 05401, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Carilion Clinic Gynecological Oncology
Roanoke Virginia, 24016, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls Wisconsin, 54729, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire Wisconsin, 54701, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua Wisconsin, 54548, United States
Ascension Saint Mary's Hospital
Rhinelander Wisconsin, 54501, United States
Marshfield Medical Center-Rice Lake
Rice Lake Wisconsin, 54868, United States
Marshfield Clinic - Weston Center
Weston Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids Wisconsin, 54494, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1916

Study ID:

NCT01139957

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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