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

Gynecologic Oncology Group (GOG)

Status: Completed

Conditions: Primary Peritoneal Carcinoma; Ovarian Neoplasm; Breast Carcinoma; Fallopian Tube Carcinoma

Treatments: Procedure: Evaluation of Cancer Risk Factors; Other: Quality-of-Life Assessment; Procedure: Study of High Risk Factors; Other: Questionnaire Administration

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01139957

NCI-2011-02233 (Registry Identifier)

GOG-8199 (Other Identifier)

CDR0000674216

U10CA101165 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,916 estimated patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

1,916 participants in 1 patient group

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.

Treatment:

Procedure: Study of High Risk Factors

Other: Quality-of-Life Assessment

Procedure: Evaluation of Cancer Risk Factors

Other: Questionnaire Administration