An observational study in Fallopian Tube Carcinoma, Hereditary Breast and Ovarian Cancer Syndrome and Ovarian Carcinoma, sponsored by Gynecologic Oncology Group. Withdrawn at 1 site in United States. Open to female participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Gynecologic Oncology Group · Observational
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.
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.
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Patients with ovarian cancer who participated in GOG-0199
Inclusion Criteria:
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.
Procedure: Evaluation of Cancer Risk Factors · Other: Medical Chart Review · Other: Study of Socioeconomic and Demographic Variables
Ancillary studies
Also known as: cancer risk factors evaluation
Ancillary study
Also known as: Chart Review
Ancillary studies
Cost-effectiveness of RRSO versus OCS
Incidence and stage at diagnosis of ovarian, fallopian tube, and peritoneal cancers in the OCS arm and in the RRSO arm will be collected. This information will be obtained from the CANCER UPDATE FORM (CA-0199) and the Ovarian Surgery Form (C-0199). Summary of the number and timing of screening serum tests, pelvic ultrasound, and surgery procedures will be used to calculate costs, and will be incorporated into the model of Markov stage that corresponds to the study timepoint at which these studies were performed.
Time frame: 6 months
This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Gynecologic Oncology Group