Cost of Cancer Risk Management in Women at Elevated Genetic Risk for Ovarian Cancer Who Participated on GOG-0199
Status: | Not yet recruiting |
---|---|
Conditions: | Breast Cancer, Ovarian Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 30 - Any |
Updated: | 4/2/2016 |
Start Date: | January 2100 |
A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer
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.
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.
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.
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.
Inclusion Criteria:
- Women who were eligible and evaluable for GOG-0199, a prospective, non-randomized,
natural history study
- Data collected from GOG-0199 available
We found this trial at
1
site
Click here to add this to my saved trials