Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer

University of Washington

Status

Completed

Conditions

Precancerous Condition

Cervical Cancer

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00458562

UWCC-6113 (Other Identifier)

UWCC-04-4928-B01 (Other Identifier)

6113

R01CA111187 (U.S. NIH Grant/Contract)

P30CA015704 (U.S. NIH Grant/Contract)

FHCRC-6113 (Other Identifier)

CDR0000482330 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,680 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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