Non Invasive Oral Cancer Screening Among HIV Infected Individuals

Summary

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

• Malignant Neoplasms of Mesothelial and Soft Tissue
• Human Immunodeficiency Virus

Interventions

BEHAVIORAL

Screening Interview

Participants asked about demographic information, and questions about history of tobacco, alcohol, and mouthwash use. Interview lasts about 7 minutes.

DEVICE

Carbon Monoxide Test

Carbon monoxide testing given to participants at baseline. Participants blow into a device that measures the amount of carbon monoxide in the lungs.

BEHAVIORAL

Self-Help Materials

Participants who want to stop smoking are given referral information for a tobacco cessation program at baseline. Participants with premalignant and malignant oral lesions \[PMOL\]) given printed materials and web-based programs for tobacco and alcohol cessation.

PROCEDURE

Visual Oral Screening Examination

Intraoral exam performed under incandescent (white light) conditions at baseline, and again two weeks later.

PROCEDURE

Direct Fluorescent Oral Visualization Examination

Intraoral exam performed under reduced room lighting with a handheld autofluorescence imaging device at baseline, and again two weeks later.

PROCEDURE

Oral Biopsy

Premalignant and malignant oral lesions \[PMOL\]) still present 2 weeks after oral exam are biopsied.

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Irene M. Tami-Maury, DRPH · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2021-07-26

Completion

2021-07-26

Countries

• United States

Study Locations