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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00458562
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : November 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date April 9, 2007
First Posted Date April 11, 2007
Last Update Posted Date November 19, 2013
Study Start Date January 2006
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2010)
  • Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer [ Time Frame: 3 years ]
    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 ]
    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 ]
    Identify HIV-related factors (CD4 counts, viral load, HAART) which might be associated with the presence or acquisition of specific hypermethylated genes.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer
Official Title HIV-Associated DNA Hypermethylation in Cervical Cancer
Brief Summary

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.

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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Cervical Cancer
  • Precancerous Condition
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 16, 2012)
1680
Original Enrollment
 (submitted: April 9, 2007)
1150
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Senegal
Removed Location Countries  
 
Administrative Information
NCT Number NCT00458562
Other Study ID Numbers 6113
R01CA111187 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
UWCC-6113 ( Other Identifier: Fred Hutchinson/University of Washington Cancer Consortium )
UWCC-04-4928-B01 ( Other Identifier: Fred Hutchinson/University of Washington Cancer Consortium )
FHCRC-6113 ( Other Identifier: Fred Hutchinson/University of Washington Cancer Consortium )
CDR0000482330 ( Registry Identifier: PDQ )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Washington
Study Sponsor University of Washington
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Nancy B. Kiviat, MD Harborview Injury Prevention and Research Center
PRS Account University of Washington
Verification Date November 2013