Breast Cancer Clinical Trial

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

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.

View Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

2605

Study ID:

NCT01445275

Recruitment Status:

Not yet recruiting

Sponsor:

Gynecologic Oncology Group

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Gynecologic Oncology Group
Philadelphia Pennsylvania, 19103, United States More Info
Laura J. Havrilesky
Contact
919-684-3765
[email protected]
Laura J. Havrilesky
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

2605

Study ID:

NCT01445275

Recruitment Status:

Not yet recruiting

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider