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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Carcinoma, Fallopian Tube Carcinoma, Ovarian Neoplasm, Primary Peritoneal Carcinoma

Intervention / Treatment
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* Procedure: Evaluation of Cancer Risk Factors
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Procedure: Study of High Risk Factors


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-correlative<br>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. | Procedure: Evaluation of Cancer Risk Factors<br>* Ancillary studies<br>* Other names: cancer risk factors evaluation;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Study of High Risk Factors<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Up to 5 years | 
| Breast cancer mortality rates |  | Up to 5 years | 
| Quality of life |  | Up to 5 years |