Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01139957
First received: June 8, 2010
Last updated: July 18, 2012
Last verified: July 2012

June 8, 2010
July 18, 2012
June 2010
December 2015   (final data collection date for primary outcome measure)
  • Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer [ Designated as safety issue: No ]
  • Ovarian cancer mortality rates [ Designated as safety issue: No ]
  • Breast cancer mortality rates [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01139957 on ClinicalTrials.gov Archive Site
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Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer
Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants

RATIONALE: Gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.

PURPOSE: This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer.

OBJECTIVES:

  • To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known BRCA1/2 mutation carriers.
  • To develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening.
  • To compare the cancer rates between these two groups of women.
  • To better characterize the similarities and differences in cancer risk between BRCA mutation-positive families and BRCA mutation-negative/family history-positive families.
  • To develop preliminary estimates of overall and cancer-specific mortality, stratified by mutation status (BRCA1-positive, BRCA2-positive, BRCA1/2-negative).

OUTLINE: This is a multicenter study.

Patients complete the Health Update Questionnaire annually for up to 5 years. The questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer.

Observational
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  • Breast Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Other: questionnaire administration
  • Procedure: evaluation of cancer risk factors
  • Procedure: quality-of-life assessment
  • Procedure: study of high risk factors
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1916
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December 2015   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Enrolled on GOG-0199

    • Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer
    • Completed the Off-Study form (Form Q0-0199 submitted via SEDES)
    • No patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Female
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01139957
CDR0000674216, GOG-8199
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Philip J. DiSaia, Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Mark H. Greene, MD Clinical Genetics Branch
National Cancer Institute (NCI)
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP