Cervical Cancer Clinical Trial
Official title:
HIV-Associated DNA Hypermethylation in Cervical Cancer
RATIONALE: Finding certain changes in genes may help doctors predict which patients are at
risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may
help the study of cancer in the future.
PURPOSE: This clinical trial is studying genes that may predict which patients are at risk
of developing cervical intraepithelial neoplasia or invasive cervical cancer.
OBJECTIVES:
- Utilize molecular assays to identify a panel of hypermethylated genes that are
predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical
cancer (ICC) among patients with or without HIV infection.
- Perform a nested case-control study assessing the risk of developing CIN3 in
relationship to human papillomavirus (HPV) persistence, HIV, and the presence or
acquisition of candidate hypermethylated genes in these patients.
- Identify HIV-related factors (e.g., CD4 counts, viral load, and highly active
antiretroviral therapy [HAART]) that might be associated with the presence or
acquisition of specific hypermethylated genes in these patients.
OUTLINE: This is a longitudinal, multicenter study.
Patients undergo biopsy for removal of cervical tissue. Patients also undergo blood and
urine sample collection. Samples are analyzed for the presence of cancer or changes that
indicate that cancer might develop. Patients also undergo colposcopy at baseline and at 3
years.
After completion of study procedures, patients are followed every 4 months for up to 3
years.
PROJECTED ACCRUAL: A total of 1,150 patients will be accrued for this study.
;
Observational Model: Case Control, Time Perspective: Prospective
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