Status:
COMPLETED
Folic Acid Clinical Trial for the Prevention of Cervical Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Precancerous Condition
Eligibility:
FEMALE
19-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Supplements, such as folic acid, may stop or delay the development of cervical cancer in women infected with human papillomavirus. PURPOSE: This phase II trial is studying how well folic a...
Detailed Description
OBJECTIVES: Primary * Evaluate the effects of folic acid supplementation on clearance of human papilloma virus (HPV) 16 and other specific types of HR-HPV and on prevention of the progression of ≤ c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Received care at the Health Departments in Alabama and with an abnormal pap result, including any of the following:
- Atypical squamous cells of undetermined significance (ASCUS)
- ASCUS, cannot exclude high-grade lesion (ASCUS-H)
- Low-grade squamous intraepithelial lesion
- High-grade squamous intraepithelial lesion
- Referred to University of Alabama at Birmingham (UAB) Highlands Clinic for further colposcopic examination by Ob/Gyn physicians
- Tested positive for human papilloma virus (HPV) 16 and diagnosed with ≤ cervical intraepithelial neoplasia (CIN) 1 lesions at the 0-month visit
- With or without concurrent infections with other HR (High Risk) HPV types (HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68)
- Not diagnosed with true preneoplastic lesions of the cervix based on a colposcopically directed biopsy
- PATIENT CHARACTERISTICS:
- Not pregnant
- Willing to take study pills, keep scheduled follow-up study visits, or communicate with study personnel about changes in contact information during the study period
- No prior diagnosis or treatment for colon polyps or breast lumps
- PRIOR CONCURRENT THERAPY:
- No prior treatment for cervical cancer or precancerous condition
- No prior surgeries involving the cervix
- No concurrent antifolate medications such as methotrexate, sulfasalazine or phenytoin
- No concurrent or planned consumption of 400 μg or more of a folic acid supplement on a regular basis
- Not involved in any other clinical trial
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00703196
Start Date
March 1 2007
Last Update
October 8 2015
Active Locations (1)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294