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

NCT ID: NCT01445275

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Evaluation of Cancer Risk Factors

Intervention Type PROCEDURE

Ancillary studies

Medical Chart Review

Intervention Type OTHER

Ancillary study

Study of Socioeconomic and Demographic Variables

Intervention Type OTHER

Ancillary studies

Interventions

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Evaluation of Cancer Risk Factors

Ancillary studies

Intervention Type PROCEDURE

Medical Chart Review

Ancillary study

Intervention Type OTHER

Study of Socioeconomic and Demographic Variables

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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cancer risk factors evaluation Chart Review

Eligibility Criteria

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Inclusion Criteria

* Women who were eligible and evaluable for GOG-0199, a prospective, non-randomized, natural history study
* Data collected from GOG-0199 available
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Havrilesky

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-03467

Identifier Type: REGISTRY

Identifier Source: secondary_id

GOG-8030

Identifier Type: -

Identifier Source: secondary_id

CDR0000712395

Identifier Type: -

Identifier Source: secondary_id

GOG-8030

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-8030

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-8030

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA101165

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-8030

Identifier Type: -

Identifier Source: org_study_id

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