Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer
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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 |
- 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.
| Estimated Enrollment: | 1680 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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 |
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.
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| Senegal | |
| Centre Hospitalier Universite De Fann | |
| Dakar, Senegal, BP 5035 | |
| Hopital Aristide Le Dantec | |
| Dakar, Senegal, BP 5126 | |
| Principal Investigator: | Nancy B. Kiviat, MD | Harborview Injury Prevention and Research Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Nancy Kiviat, MD, FHCRC/UW CC |
| 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: | March 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
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 February 24, 2013
