Overview

This trial is active, not recruiting.

Conditions breast carcinoma, fallopian tube carcinoma, ovarian neoplasm, primary peritoneal carcinoma
Treatments evaluation of cancer risk factors, quality-of-life assessment, questionnaire administration, study of high risk factors
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date June 2010
End date December 2015
Trial size 1916 participants
Trial identifier NCT01139957, CDR0000674216, GOG-8199, NCI-2011-02233, U10CA101165

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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.
evaluation of cancer risk factors cancer risk factors evaluation
Ancillary studies
quality-of-life assessment Quality of Life Assessment
Ancillary studies
questionnaire administration
Ancillary studies
study of high risk factors
Ancillary studies

Primary Outcomes

Measure
Breast cancer mortality rates
time frame: Up to 5 years
Ovarian cancer mortality rates
time frame: Up to 5 years
Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer
time frame: Up to 5 years
Quality of life
time frame: Up to 5 years

Eligibility Criteria

Female participants at least 30 years old.

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)

Additional Information

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
Principal investigator Mark Greene
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.