Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00458562

Purpose

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.

Condition	Intervention
Cervical Cancer Precancerous/Nonmalignant Condition	Procedure: DNA methylation analysis Procedure: biopsy Procedure: colposcopic biopsy Procedure: gene expression analysis Procedure: laboratory biomarker analysis Procedure: study of high risk factors

MedlinePlus related topics: AIDS Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	HIV-Associated DNA Hypermethylation in Cervical Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer [ Designated as safety issue: No ]
Assessment of the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes [ Designated as safety issue: No ]
Identification of HIV-related factors associated with the presence or acquisition of specific hypermethylated genes [ Designated as safety issue: No ]

Estimated Enrollment:	1150
Study Start Date:	January 2006
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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)
Intact cervix

PATIENT CHARACTERISTICS:

Not pregnant

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458562

Locations

Senegal
Centre Hospitalier Universite De Fann	Recruiting
Dakar, Senegal, BP 5035
Contact: Papa Salif Sow, MD 221-824-7092
Hopital Aristide Le Dantec	Recruiting
Dakar, Senegal, BP 5126
Contact: Papa Toure, MD 221-822-3702

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Nancy B. Kiviat, MD

Fred Hutchinson Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000482330, UWCC-UW-6113, UWCC-04-4928-B01, FHCRC-6113
Study First Received:	April 9, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00458562
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Precancerous Conditions
HIV Infections
Cervical intraepithelial neoplasia
Carcinoma in Situ

Acquired Immunodeficiency Syndrome
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009