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

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT01445275
Collaborator
National Cancer Institute (NCI) (NIH)
2,605
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Evaluation of Cancer Risk Factors
  • Other: Medical Chart Review
  • Other: Study of Socioeconomic and Demographic Variables

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2605 participants
Time Perspective:
Retrospective
Official Title:
A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer
Study Start Date :
Jan 1, 2100
Anticipated Primary Completion Date :
Jan 1, 2100

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: Evaluation of Cancer Risk Factors
Ancillary studies
Other Names:
  • cancer risk factors evaluation

    • Other: Medical Chart Review
    Ancillary study
    Other Names:
  • Chart Review

    • Other: Study of Socioeconomic and Demographic Variables
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Cost-effectiveness of RRSO versus OCS [6 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    • Data collected from GOG-0199 available

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gynecologic Oncology Group Philadelphia Pennsylvania United States 19103

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Laura Havrilesky, Gynecologic Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynecologic Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01445275
    Other Study ID Numbers:
    • GOG-8030
    • NCI-2011-03467
    • GOG-8030
    • CDR0000712395
    • GOG-8030
    • GOG-8030
    • GOG-8030
    • U10CA101165
    First Posted:
    Oct 3, 2011
    Last Update Posted:
    May 29, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Carcinoma
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Hereditary Breast and Ovarian Cancer Syndrome

    Study Results

    No Results Posted as of May 29, 2015