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
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1916
Study Start Date: June 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139957

  Show 95 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Mark H. Greene, MD Clinical Genetics Branch
  More Information

Additional Information:
No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01139957     History of Changes
Other Study ID Numbers: CDR0000674216, GOG-8199
Study First Received: June 8, 2010
Last Updated: July 18, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ovarian neoplasm
fallopian tube cancer
breast cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on May 22, 2013