Status:
WITHDRAWN
CA-125 in Screening Patients at High Risk for Ovarian Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
30+ years
Brief Summary
RATIONALE: Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment. PURPOSE: This...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility of prospective screening for ovarian cancer in high-risk patients. * Determine normal ranges and distributions of CA 125 within and between these pati...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- At high risk for developing ovarian cancer, as determined by meeting criteria for 1 of the following:
- Family history of at least 2 ovarian or breast\* cancers among the patient and first- and second-degree relatives within the same lineage\*\*
- If breast cancer\* is required to meet this criterion, at least 1 breast cancer\* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown) NOTE: \*\*Multiple primary cancers in the same person satisfies this criterion
- Ashkenazi Jewish ethnicity and meets criteria for 1 of the following:
- Prior breast cancer\* diagnosis
- One first-degree or 2 second-degree relatives with breast\* or ovarian cancer
- If breast cancer is required to meet this criterion, at least 1 breast cancer\* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown)
- Probability of BRCA1 or BRCA2 mutation greater than 20%, as determined by BRCAPRO 95% posterior probability interval
- This criterion includes the following situations for which BRCAPRO is not required:
- Tested positive for a BRCA1 or BRCA2 mutation (100% probability)
- First- or second-degree relative with a BRCA1 or BRCA2 mutation NOTE: \*Including ductal carcinoma in situ
- No ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum
- PATIENT CHARACTERISTICS:
- Age
- 30 and over
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- No hemophilia
- No other bleeding disorders
- Hepatic
- Not specified
- Renal
- Not specified
- Pulmonary
- No emphysema
- Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric or psychological condition that would preclude giving informed consent
- No concurrent untreated malignancy except nonmelanoma skin cancer
- No other medical condition that would preclude blood draws (e.g., chronic infectious disease)
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- More than 3 months since prior adjuvant chemotherapy for cancer
- Endocrine therapy
- Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed
- Radiotherapy
- More than 3 months since prior adjuvant radiotherapy for cancer
- Surgery
- More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy)
- Prior prophylactic oophorectomy allowed
- Other
- More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy
- No concurrent participation in other ovarian cancer early detection trials
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00080639
Start Date
June 1 2003
End Date
June 1 2007
Last Update
August 5 2013
Active Locations (1)
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1
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300