Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Birmingham, Alabama 35294


Purpose:

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 phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer.


Study summary:

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 patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy). Secondary - Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients. OUTLINE: This is a multicenter, pilot study. Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results. Patients are followed at 6 months and then annually thereafter. PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.


Criteria:

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


NCT ID:

NCT00080639


Primary Contact:

Principal Investigator
Edward E. Partridge, MD
University of Alabama at Birmingham


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.