Clinical trial · Interventional
Non Invasive Oral Cancer Screening Among HIV Infected Individuals
Non-invasive Oral Cancer Screening Among Individuals Who Have HIV Infection
NCT02823847CI-TRIAL-00056515completedEarly Phase 1ClinicalTrials.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)
The goal of this clinical research study is to learn how a new method for performing oral (mouth) exams can help doctors check for suspicious lesions (called premalignant and malignant oral lesions \[PMOL\]) in the mouth of HIV-infected smokers.
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 |
|---|---|---|---|
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| Malignant Neoplasms of Mesothelial and Soft Tissue | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon Monoxide Test | Device | — | UNRESOLVED |
| Direct Fluorescent Oral Visualization Examination | Procedure | — | UNRESOLVED |
| Oral Biopsy | Procedure | — | UNRESOLVED |
| Screening Interview | Behavioral | — | UNRESOLVED |
| Self-Help Materials | Behavioral | — | UNRESOLVED |
| Visual Oral Screening Examination | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Screening
- description
- Participants given a screening interview at baseline. Carbon monoxide testing given to participants at baseline. Participants who want to stop smoking are given referral information for a tobacco cessation program. Participants undergo an oral examination using conventional light, and oral examination using a fluorescence light-based hand held device at baseline, and again two weeks later. Oral lesions still present after two weeks are biopsied. Participants with premalignant and malignant oral lesions \[PMOL\]) given printed materials and web-based programs for tobacco and alcohol cessation.
- interventionNames
- Behavioral: Screening Interview
- Device: Carbon Monoxide Test
- Behavioral: Self-Help Materials
- Procedure: Visual Oral Screening Examination
- Procedure: Direct Fluorescent Oral Visualization Examination
- Procedure: Oral Biopsy
Primary outcomes (1)
- measure
- Positive Predictive Value for Premalignant and Malignant oral lesions (PMOL)
- timeFrame
- 2 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. HIV positive individuals seeking dental care at Bering Omega/Houston Area Community Services 2. Being able to speak English and/or Spanish Exclusion Criteria: 1. patients under 18 years of age 2. patients current participation in a tobacco cessation program 3. Patients unwilling or unable to provide consent 4. Patients declining oral biopsies
References
Publications (0)
Data not yet available
No reference posted for this study.