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

Completed

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

• Registration Number: NCT01139957
• Lead Sponsor: Gynecologic Oncology Group

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 Timeline

• Study Start: 2010-06-07
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1916

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (140)

University of Alabama at Birmingham Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Gynecologic Oncology Group of Arizona; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis; 🇺🇸 Hartford, Connecticut, United States

The Hospital of Central Connecticut; 🇺🇸 New Britain, Connecticut, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Beebe Medical Center; 🇺🇸 Lewes, Delaware, United States

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