NCT01445275

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fallopian Tube Carcinoma
• Hereditary Breast and Ovarian Cancer Syndrome
• Ovarian Carcinoma
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Evaluation of Cancer Risk Factors	Ancillary studies
OTHER	Medical Chart Review	Ancillary study
OTHER	Study of Socioeconomic and Demographic Variables	Ancillary studies

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-01-01
• First posted: 2011-10-03
• Last updated: 2024-08-21

Locations

1 site across 1 country: United States