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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139957
• Other study ID #: GOG-8199
• Secondary ID: NCI-2011-02233CD
• Status: Completed
• Start date: June 7, 2010
• Est. completion date: April 10, 2020

Study information

• Verified date: August 2020
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1916
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Fallopian Tube Carcinoma
• Ovarian Neoplasm
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Procedure:
• Evaluation of Cancer Risk Factors
Ancillary studies

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Study of High Risk Factors
Ancillary studies

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Michigan Cancer Research Consortium NCORP	Ann Arbor	Michigan
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	University of Colorado Hospital	Aurora	Colorado
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	MedStar Franklin Square Medical Center/Weinberg Cancer Institute	Baltimore	Maryland
United States	Bronson Battle Creek	Battle Creek	Michigan
United States	National Institutes of Health Clinical Center	Bethesda	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Spectrum Health Big Rapids Hospital	Big Rapids	Michigan
United States	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama
United States	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho
United States	Tufts Medical Center	Boston	Massachusetts
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Aultman Health Foundation	Canton	Ohio
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	Marshfield Clinic-Chippewa Center	Chippewa Falls	Wisconsin
United States	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio
United States	University of Cincinnati/Barrett Cancer Center	Cincinnati	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	University of Missouri - Ellis Fischel	Columbia	Missouri
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Beaumont Hospital - Dearborn	Dearborn	Michigan
United States	Ascension Saint John Hospital	Detroit	Michigan
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan
United States	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin
United States	Saint Elizabeth Medical Center South	Edgewood	Kentucky
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois
United States	Genesys Regional Medical Center-West Flint Campus	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Florida Gynecologic Oncology	Fort Myers	Florida
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Unity Hospital	Fridley	Minnesota
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	Hartford Hospital	Hartford	Connecticut
United States	Smilow Cancer Hospital Care Center at Saint Francis	Hartford	Connecticut
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
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	Allegiance Health	Jackson	Michigan
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Heartland Hematology and Oncology Associates Incorporated	Kansas City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	Sparrow Hospital	Lansing	Michigan
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri
United States	Beebe Medical Center	Lewes	Delaware
United States	Liberty Radiation Oncology Center	Liberty	Missouri
United States	Nebraska Cancer Research Center	Lincoln	Nebraska
United States	Saint Mary Mercy Hospital	Livonia	Michigan
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	Norton Hospital Pavilion and Medical Campus	Louisville	Kentucky
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin
United States	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio
United States	UH Seidman Cancer Center at Lake Health Mentor Campus	Mentor	Ohio
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota
United States	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin
United States	Mercy Health Mercy Campus	Muskegon	Michigan
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Yale University	New Haven	Connecticut
United States	New Ulm Medical Center	New Ulm	Minnesota
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	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Christiana Care Health System-Christiana Hospital	Newark	Delaware
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska
United States	Alegent Health Immanuel Medical Center	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Menorah Medical Center	Overland Park	Kansas
United States	Saint Luke's South Hospital	Overland Park	Kansas
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Gynecologic Oncology Group of Arizona	Phoenix	Arizona
United States	FirstHealth of the Carolinas-Moore Regional Hospital	Pinehurst	North Carolina
United States	Saint Joseph Mercy Oakland	Pontiac	Michigan
United States	Lake Huron Medical Center	Port Huron	Michigan
United States	Maine Medical Center-Bramhall Campus	Portland	Maine
United States	Kansas City NCI Community Oncology Research Program	Prairie Village	Kansas
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Ascension Saint Mary's Hospital	Rhinelander	Wisconsin
United States	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Carilion Clinic Gynecological Oncology	Roanoke	Virginia
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	Ascension Saint Mary's Hospital	Saginaw	Michigan
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Saint Joseph Oncology Inc	Saint Joseph	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Women's Cancer Associates	Saint Petersburg	Florida
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Mayo Clinic in Arizona	Scottsdale	Arizona
United States	Saint Francis Regional Medical Center	Shakopee	Minnesota
United States	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota
United States	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Munson Medical Center	Traverse City	Michigan
United States	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma
United States	Carle Cancer Center	Urbana	Illinois
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Saint John Macomb-Oakland Hospital	Warren	Michigan
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota
United States	UMass Memorial Medical Center - Memorial Division	Worcester	Massachusetts
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	Main Line Health NCORP	Wynnewood	Pennsylvania
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer		Up to 5 years
Primary	Ovarian cancer mortality rates	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
Primary	Breast cancer mortality rates		Up to 5 years
Primary	Quality of life		Up to 5 years