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Spots Global Cancer Trial Database for Cost of Cancer Risk Management in Women at Elevated Genetic Risk for Ovarian Cancer Who Participated on GOG-0199

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Trial Identification

Brief Title: Cost of Cancer Risk Management in Women at Elevated Genetic Risk for Ovarian Cancer Who Participated on GOG-0199

Official Title: A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer

Study ID: NCT01445275

Study Description

Brief Summary: This research trial collects information about types of treatment and the cost of these procedures in women with elevated genetic risk for ovarian cancer who participated on the Gynecology Oncology Group (GOG)-0199 trial. Gathering information about women at elevated genetic risk for ovarian cancer may help doctors learn more about risk reduction procedures and the cost of these procedures.

Detailed Description: PRIMARY OBJECTIVES: I. To estimate the cost-effectiveness, defined as cost per quality-adjusted life-year saved, of risk-reducing salpingo-oophorectomy (RRSO) versus ovarian cancer screening (OCS) for women at elevated genetic risk of ovarian cancer over a five-year period, using data from GOG-0199 to model survival. SECONDARY OBJECTIVES: I. To estimate the cost-effectiveness, defined as cost per quality-adjusted life-year saved, of RRSO versus OCS for women at elevated genetic risk of ovarian cancer over a lifetime, using stage-specific cohorts and population-based data to model long-term survival. (Exploratory) II. To use value of information (VOI) methodology to set future research priorities aimed at developing evidence-based approaches to the management of women who are at elevated genetic risk of ovarian cancer. (Exploratory) OUTLINE: Outcome data, such as incidence and stage at diagnosis of ovarian, fallopian tube, and peritoneal cancers; number and timing of screening and serum tests performed; number and timing of pelvic ultrasounds performed; surgical procedures performed; cancer-specific and overall survival (if available); and the incidence, type, and grade of significant adverse events, are collected from the Gynecologic Oncology Group (GOG)-0199 records and analyzed. Cost of each medical intervention is also estimated.

Keywords

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

Contact Details

Name: Laura Havrilesky

Affiliation: Gynecologic Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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