Primary Peritoneal Carcinoma Clinical Trial
Official title:
A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer
Verified date | May 2015 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | 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.
Status | Not yet recruiting |
Enrollment | 2605 |
Est. completion date | |
Est. primary completion date | January 2100 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: - Women who were eligible and evaluable for GOG-0199, a prospective, non-randomized, natural history study - Data collected from GOG-0199 available |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Gynecologic Oncology Group | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | No |
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