Clinical trial · Observational
Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer
HIV-Associated DNA Hypermethylation in Cervical Cancer
NCT00458562CI-TRIAL-00012681completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- HIV+, <CIN2
- description
- HIV positive women without CIN2-3 or worse
- label
- HIV-, no >=CIN3 biopsy, HR HPV+
- description
- HIV negative women without biopsy-proven CIN3 or worse, and with high risk HPV infection
- label
- HIV-, <=CIN1, HPV- at screening
- description
- HIV negative women who are \<= CIN1 and HPV negative at screening
Primary outcomes (3)
- measure
- Identification of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 consentReferences
Publications (0)
Data not yet available
No reference posted for this study.