Know Cancer

or
forgot password

A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer


N/A
30 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer


OBJECTIVES:

Primary

- 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

- 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)

- 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


DISEASE CHARACTERISTICS:

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

- Data collected from GOG-0199 available

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Health Services Research

Outcome Measure:

Cost-effectiveness of RRSO versus OCS

Safety Issue:

No

Principal Investigator

Laura J. Havrilesky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

Unspecified

Study ID:

CDR0000712395

NCT ID:

NCT01445275

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • hereditary breast/ovarian cancer (BRCA1, BRCA2)
  • ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location