Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer
- Conditions
- Fallopian Tube CarcinomaPrimary Peritoneal CarcinomaOvarian NeoplasmBreast Carcinoma
- Interventions
- Procedure: Evaluation of Cancer Risk FactorsOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationProcedure: Study of High Risk Factors
- Registration Number
- NCT01139957
- Lead Sponsor
- Gynecologic Oncology Group
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1916
-
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)
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-correlative Evaluation of Cancer Risk Factors 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. Ancillary-correlative Questionnaire Administration 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. Ancillary-correlative Quality-of-Life Assessment 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. Ancillary-correlative Study of High Risk Factors 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.
- Primary Outcome Measures
Name Time Method Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer Up to 5 years Ovarian cancer mortality rates Up to 5 years Cox proportional hazards models will be used to compare the incidence rates between the risk-reducing salpingo-oophorectomy (RRSO) and screening groups, adjusting for appropriate covariates. If necessary, modeling will be carried out in order to use non-proportional hazards models.
Breast cancer mortality rates Up to 5 years Quality of life Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (140)
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Cincinnati/Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
UCLA / Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Smilow Cancer Hospital Care Center at Saint Francis
🇺🇸Hartford, Connecticut, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Women's Cancer Associates
🇺🇸Saint Petersburg, Florida, United States
Florida Gynecologic Oncology
🇺🇸Fort Myers, Florida, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
University of Chicago Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
🇺🇸Evanston, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Saint Luke's South Hospital
🇺🇸Overland Park, Kansas, United States
Kansas City NCI Community Oncology Research Program
🇺🇸Prairie Village, Kansas, United States
Saint Elizabeth Medical Center South
🇺🇸Edgewood, Kentucky, United States
Maine Medical Center-Bramhall Campus
🇺🇸Portland, Maine, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
🇺🇸Baltimore, Maryland, United States
Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
UMass Memorial Medical Center - Memorial Division
🇺🇸Worcester, Massachusetts, United States
Bronson Battle Creek
🇺🇸Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
🇺🇸Big Rapids, Michigan, United States
Beaumont Hospital - Dearborn
🇺🇸Dearborn, Michigan, United States
Ascension Saint John Hospital
🇺🇸Detroit, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
🇺🇸Flint, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
🇺🇸Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Saint Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Mercy Health Mercy Campus
🇺🇸Muskegon, Michigan, United States
Saint Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Lake Huron Medical Center
🇺🇸Port Huron, Michigan, United States
Ascension Saint Mary's Hospital
🇺🇸Rhinelander, Wisconsin, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Michigan, United States
Saint John Macomb-Oakland Hospital
🇺🇸Warren, Michigan, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Unity Hospital
🇺🇸Fridley, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
New Ulm Medical Center
🇺🇸New Ulm, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
North Memorial Medical Health Center
🇺🇸Robbinsdale, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
🇺🇸Shakopee, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
University of Missouri - Ellis Fischel
🇺🇸Columbia, Missouri, United States
Saint Luke's East - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Liberty Radiation Oncology Center
🇺🇸Liberty, Missouri, United States
Saint Joseph Oncology Inc
🇺🇸Saint Joseph, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Nebraska Cancer Research Center
🇺🇸Lincoln, Nebraska, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Aultman Health Foundation
🇺🇸Canton, Ohio, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
🇺🇸Mentor, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Hillcrest Hospital Cancer Center
🇺🇸Mayfield Heights, Ohio, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Main Line Health NCORP
🇺🇸Wynnewood, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic
🇺🇸Sioux Falls, South Dakota, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Carilion Clinic Gynecological Oncology
🇺🇸Roanoke, Virginia, United States
Marshfield Clinic-Chippewa Center
🇺🇸Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
🇺🇸Eau Claire, Wisconsin, United States
Marshfield Clinic-Minocqua Center
🇺🇸Minocqua, Wisconsin, United States
Marshfield Medical Center-Marshfield
🇺🇸Marshfield, Wisconsin, United States
Marshfield Medical Center-Rice Lake
🇺🇸Rice Lake, Wisconsin, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Gynecologic Oncology Group of Arizona
🇺🇸Phoenix, Arizona, United States
University of Alabama at Birmingham Cancer Center
🇺🇸Birmingham, Alabama, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Allegiance Health
🇺🇸Jackson, Michigan, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States
Michigan Cancer Research Consortium NCORP
🇺🇸Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Norton Hospital Pavilion and Medical Campus
🇺🇸Louisville, Kentucky, United States
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States