Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer
Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive 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.
INCLUSION CRITERIA:

 -  Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any
 of the following criteria:

 -  Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or
 invasive cervical cancer (ICC), meeting any of the following criteria:

 -  CIN grade 2-3 or higher

 -  Repeated CIN1 (times 6)

 -  Abnormal Pap smear (atypical squamous cells of undetermined significance
 [ASCUS] or worse)

 -  HIV seropositive

 -  Negative cytology but positive for high-risk human papillomavirus (HPV)

 -  Negative cytology and negative HPV

 -  HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection
 (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)

 -  >= 18 years of age

 -  Intact cervix

 -  Not pregnant

 -  Able to provide informed consent

 EXCLUSION CRITERIA:

 -  < 18 years of age

 -  Pregnant at screening

 -  Cervix not intact

 -  not able to provide informed consent