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

August 31, 2020 updated by: Gynecologic Oncology Group

Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1916

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Gynecologic Oncology Group of Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • Florida
      • Fort Myers, Florida, United States, 33905
        • Florida Gynecologic Oncology
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Saint Petersburg, Florida, United States, 33701
        • Women's Cancer Associates
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital and Health Care Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66213
        • Saint Luke's South Hospital
      • Prairie Village, Kansas, United States, 66208
        • Kansas City NCI Community Oncology Research Program
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Medical Center South
      • Louisville, Kentucky, United States, 40202
        • Norton Hospital Pavilion and Medical Campus
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center-Bramhall Campus
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center
      • Elkton, Maryland, United States, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center - Memorial Division
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Cancer Research Consortium NCORP
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Big Rapids, Michigan, United States, 49307
        • Spectrum Health Big Rapids Hospital
      • Dearborn, Michigan, United States, 48124
        • Beaumont Hospital - Dearborn
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48236
        • Ascension Saint John Hospital
      • Flint, Michigan, United States, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Mercy Health Saint Mary's
      • Grand Rapids, Michigan, United States, 49503
        • Cancer Research Consortium of West Michigan NCORP
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Mercy Campus
      • Pontiac, Michigan, United States, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Lake Huron Medical Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, United States, 48601
        • Ascension Saint Mary's Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota/Masonic Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri - Ellis Fischel
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Lee's Summit, Missouri, United States, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, United States, 64068
        • Liberty Radiation Oncology Center
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, United States, 64507
        • Saint Joseph Oncology Inc
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Nebraska Cancer Research Center
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, United States, 68106
        • Missouri Valley Cancer Consortium
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati/Barrett Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health NCORP
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Lackland Air Force Base, Texas, United States, 78236
        • Wilford Hall Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic Gynecological Oncology
    • Wisconsin
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Rhinelander, Wisconsin, United States, 54501
        • Ascension Saint Mary's Hospital
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients in the GOG-0199 protocol

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ancillary-correlative
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Evaluation of Cancer Risk Factors
Ancillary studies
Other Names:
  • cancer risk factors evaluation
Procedure: Study of High Risk Factors
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Up to 5 years
Up to 5 years
Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer
Time Frame: Up to 5 years
Up to 5 years
Ovarian cancer mortality rates
Time Frame: 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.
Up to 5 years
Breast cancer mortality rates
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mark H Greene, Gynecologic Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2010

Primary Completion (Actual)

April 10, 2020

Study Completion (Actual)

April 10, 2020

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-8199 (Other Identifier: CTEP)
  • U10CA101165 (U.S. NIH Grant/Contract)
  • NCI-2011-02233 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000674216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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