Brief Title
Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer
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
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.
Study Type
Observational
Primary Outcome
Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer
Condition
Breast Carcinoma
Intervention
Evaluation of Cancer Risk Factors
Study Arms / Comparison Groups
Ancillary-correlative
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
1916
Start Date
June 7, 2010
Completion Date
April 10, 2020
Primary Completion Date
April 10, 2020
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)
Gender
Female
Ages
30 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mark H Greene, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01139957
Organization ID
GOG-8199
Secondary IDs
NCI-2011-02233
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Mark H Greene, Principal Investigator, Gynecologic Oncology Group
Verification Date
August 2020