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

Cervical Cancer Clinical Trial

Official title:

HIV-Associated DNA Hypermethylation in Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458562
• Other study ID #: 6113
• Secondary ID: R01CA111187P30CA
• Status: Completed
• Phase: N/A
• First received: April 9, 2007
• Last updated: November 15, 2013
• Start date: January 2006
• Est. completion date: November 2012

Study information

• Verified date: November 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1680
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Senegal	Centre Hospitalier Universite De Fann	Dakar
Senegal	Hopital Aristide Le Dantec	Dakar

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer	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.	3 years	No
Primary	Assessment of the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes	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.	3 years	No
Primary	Identification of HIV-related factors associated with the presence or acquisition of specific hypermethylated genes	Identify HIV-related factors (CD4 counts, viral load, HAART) which might be associated with the presence or acquisition of specific hypermethylated genes.	3 years	No