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HIV-Associated DNA Hypermethylation in Cervical Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Precancerous Condition

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Trial Information

HIV-Associated DNA Hypermethylation in 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


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer

Outcome Description:

Use molecular assays to identify a panel of hypermethylated genes that are predictive of CIN-3/ICC among women with and without HIV infection. We will rank genes by their ability to discriminate normal cervical tissue from CIN-3/ICC after stratifying by HIV infection.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Nancy B. Kiviat, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Harborview Injury Prevention and Research Center

Authority:

United States: Institutional Review Board

Study ID:

6113

NCT ID:

NCT00458562

Start Date:

January 2006

Completion Date:

December 2013

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • atypical squamous cells of undetermined significance
  • stage 0 cervical cancer
  • cervical intraepithelial neoplasia grade 1
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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