Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer
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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 |
- 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) |
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 |
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
Show 95 Study Locations| 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 Endocrine Gland Neoplasms Ovarian Diseases Genital Neoplasms, Female Urogenital Neoplasms Abdominal Neoplasms |
Digestive System Neoplasms Breast Diseases Skin Diseases Adnexal Diseases Genital Diseases, Female Endocrine System Diseases Gonadal Disorders Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on May 16, 2013