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

G

Gynecologic Oncology Group (GOG)

Status

Withdrawn

Conditions

Primary Peritoneal Carcinoma
Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Carcinoma
Fallopian Tube Carcinoma

Treatments

Other: Medical Chart Review
Other: Study of Socioeconomic and Demographic Variables
Procedure: Evaluation of Cancer Risk Factors

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01445275
NCI-2011-03467 (Registry Identifier)
GOG-8030
CDR0000712395
U10CA101165 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 1 patient group

Ancillary-Correlative (Health Services Research)
Description:
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.
Treatment:
Procedure: Evaluation of Cancer Risk Factors
Other: Study of Socioeconomic and Demographic Variables
Other: Medical Chart Review

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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