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
  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
Cervical Cancer
Precancerous Condition

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: HIV-Associated DNA Hypermethylation in Cervical Cancer

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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


Enrollment: 1680
Study Start Date: January 2006
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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

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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Senegal
Centre Hospitalier Universite De Fann
Dakar, Senegal, BP 5035
Hopital Aristide Le Dantec
Dakar, Senegal, BP 5126
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Nancy B. Kiviat, MD Harborview Injury Prevention and Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00458562     History of Changes
Other Study ID Numbers: 6113, R01CA111187, P30CA015704, UWCC-6113, UWCC-04-4928-B01, FHCRC-6113, CDR0000482330
Study First Received: April 9, 2007
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
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

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Precancerous Conditions
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 18, 2014