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
4 other identifiers
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 30, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedAugust 21, 2024
August 1, 2024
5 years
September 30, 2011
August 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Ancillary-Correlative (Health Services Research)
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.
Interventions
Ancillary studies
Ancillary study
Ancillary studies
Eligibility Criteria
Patients with ovarian cancer who participated in GOG-0199
You may qualify if:
- Women who were eligible and evaluable for GOG-0199, a prospective, non-randomized, natural history study
- Data collected from GOG-0199 available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Havrilesky
Gynecologic Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2011
First Posted
October 3, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2016
Last Updated
August 21, 2024
Record last verified: 2024-08