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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.
Verified May 2015 by Gynecologic Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT01445275
First Posted: October 3, 2011
Last Update Posted: May 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  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 ]
    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 Name: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Laura Havrilesky Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01445275     History of Changes
Other Study ID Numbers: GOG-8030
NCI-2011-03467 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000712395
GOG-8030 ( Other Identifier: Gynecologic Oncology Group )
GOG-8030 ( Other Identifier: DCP )
GOG-8030 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Submitted: September 30, 2011
First Posted: October 3, 2011
Last Update Posted: May 29, 2015
Last Verified: May 2015

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