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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

30 Years
Open (Enrolling)
Breast Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


- 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 BRCA1/2 mutation

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

- To compare the cancer rates between these two groups of women.

- To better characterize the similarities and differences in cancer risk between BRCA
mutation-positive families and BRCA mutation-negative/family history-positive families.

- 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.

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)


- Not specified


- See Disease Characteristics

Type of Study:


Study Design:


Outcome Measure:

Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer

Safety Issue:


Principal Investigator

Mark H. Greene, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Clinical Genetics Branch


United States: Federal Government

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • ovarian neoplasm
  • fallopian tube cancer
  • breast cancer
  • primary peritoneal cavity cancer
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



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