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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2015 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01445275
First received: September 30, 2011
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Fallopian Tube Carcinoma
Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Procedure: Evaluation of Cancer Risk Factors
Other: Medical Chart Review
Other: Study of Socioeconomic and Demographic Variables

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Comparative Effectiveness Study of Cancer Risk Management for Women at Elevated Genetic Risk of Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Cost-effectiveness of RRSO versus OCS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Incidence and stage at diagnosis of ovarian, fallopian tube, and peritoneal cancers in the OCS arm and in the RRSO arm will be collected. This information will be obtained from the CANCER UPDATE FORM (CA-0199) and the Ovarian Surgery Form (C-0199). Summary of the number and timing of screening serum tests, pelvic ultrasound, and surgery procedures will be used to calculate costs, and will be incorporated into the model of Markov stage that corresponds to the study timepoint at which these studies were performed.


Estimated Enrollment: 2605
Study Start Date: January 2100
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Evaluation of Cancer Risk Factors
Ancillary studies
Other Name: cancer risk factors evaluation
Other: Medical Chart Review
Ancillary study
Other Names:
  • Chart Review
  • Medical Chart Review
Other: Study of Socioeconomic and Demographic Variables
Ancillary studies

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ovarian cancer who participated in GOG-0199

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445275

Locations
United States, Pennsylvania
Gynecologic Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Laura J. Havrilesky    919-684-3765    havri001@mc.duke.edu   
Principal Investigator: Laura J. Havrilesky         
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Laura Havrilesky Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01445275     History of Changes
Other Study ID Numbers: GOG-8030, NCI-2011-03467, GOG-8030, CDR0000712395, GOG-8030, GOG-8030, GOG-8030, U10CA101165
Study First Received: September 30, 2011
Last Updated: May 27, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Fallopian Tube Neoplasms
Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Breast Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on August 27, 2015