Cost of Cancer Risk Management in Women at Elevated Genetic Risk for Ovarian Cancer Who Participated on GOG-0199
Conditions
Fallopian Tube Carcinoma - Hereditary Breast and Ovarian Cancer Syndrome - Ovarian Carcinoma - Primary Peritoneal Carcinoma
Conditions: official terms
Carcinoma - Fallopian Tube Neoplasms - Hereditary Breast and Ovarian Cancer Syndrome - Ovarian Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Retrospective
Intervention
Name: Evaluation of Cancer Risk Factors Type: Procedure
Name: Medical Chart Review Type: Other
Name: Study of Socioeconomic and Demographic Variables Type: Other
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 30 Years
Gender: Female
Criteria: Inclusion Criteria:

- Women who were eligible and evaluable for GOG-0199, a prospective, non-randomized, natural history study

- Data collected from GOG-0199 available
Location
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Laura J. Havrilesky - 919-684-3765 - havri001@mc.duke.edu
Start Date
January 2100
Sponsors
Gynecologic Oncology Group
Source
Gynecologic Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page