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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00458562
First received: April 9, 2007
Last updated: November 15, 2013
Last verified: November 2013

April 9, 2007
November 15, 2013
January 2006
November 2012   (final data collection date for primary outcome measure)
  • Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.
  • Assessment of the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Perform a nested case control study assessing the risk of developing CIN-3 in relationship to HPV persistence, HIV, and the presence or acquisition of the candidate hypermethylated genes.
  • Identification of HIV-related factors associated with the presence or acquisition of specific hypermethylated genes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Identify HIV-related factors (CD4 counts, viral load, HAART) which might be associated with the presence or acquisition of specific hypermethylated genes.
Not Provided
Complete list of historical versions of study NCT00458562 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer
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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cervical brush in PreservCyt, cervical swab in STM, cervical swab in Roche media, whole blood, void urine, cervical tissue biopsy.

Non-Probability Sample

All study participants will be African women presenting to the clinical sites in Dakar, Senegal. Subjects will be representative of ethnic and racial groups living in Senegal.

  • Cervical Cancer
  • Precancerous Condition
Not Provided
  • HIV+, <CIN2
    HIV positive women without CIN2-3 or worse
  • HIV-, no >=CIN3 biopsy, HR HPV+
    HIV negative women without biopsy-proven CIN3 or worse, and with high risk HPV infection
  • HIV-, <=CIN1, HPV- at screening
    HIV negative women who are <= CIN1 and HPV negative at screening
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1680
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Senegal
 
NCT00458562
6113, R01CA111187, P30CA015704, UWCC-6113, UWCC-04-4928-B01, FHCRC-6113, CDR0000482330
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Nancy B. Kiviat, MD Harborview Injury Prevention and Research Center
University of Washington
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP