Folic Acid Clinical Trial for the Prevention of Cervical Cancer (NCT00703196) | Clinical Trial Compass
CompletedPhase 2
Folic Acid Clinical Trial for the Prevention of Cervical Cancer
United States368 participantsStarted 2007-03
Plain-language 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 acid supplements work in preventing cancer in women infected with human papillomavirus.
Who can participate
Age range19 Years – 120 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Clearance of HPV 16 and other coexisting HR-HPV and incidence of CIN ≥ 2