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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1680 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer Precancerous Condition

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIV+, <CIN2

HIV positive women without CIN2-3 or worse

No interventions assigned to this group

HIV-, no >=CIN3 biopsy, HR HPV+

HIV negative women without biopsy-proven CIN3 or worse, and with high risk HPV infection

No interventions assigned to this group

HIV-, <=CIN1, HPV- at screening

HIV negative women who are \<= CIN1 and HPV negative at screening

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nancy B. Kiviat, MD

Role: PRINCIPAL_INVESTIGATOR

Harborview Injury Prevention and Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Universite De Fann

Dakar, , Senegal

Site Status

Hopital Aristide Le Dantec

Dakar, , Senegal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Senegal