Non Invasive Oral Cancer Screening Among HIV Infected Individuals

NCT02823847 | Completed Early Phase 1

• 2 other identifiers: 2015-1030NCI-2016-01073
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Malignant neoplasms of mesothelial and soft tissue; Human immunodeficiency virus; HIV; Carbon monoxide test; Self-help materials; Visual Oral Screening Examination; Direct Fluorescent Oral Visualization Examination; Oral Biopsy

Outcome Measures

Primary Outcomes (1)

• Positive Predictive Value for Premalignant and Malignant oral lesions (PMOL)

  Positive predictive value defined as the number of true positives (confirmed PMOLs) divided by the total number of suspicious lesions.

  2 weeks

Study Arms (1)

Oral Screening

EXPERIMENTAL

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.

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

Interventions

Screening Interview BEHAVIORAL

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

Oral Screening

Carbon Monoxide Test DEVICE

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

Oral Screening

Self-Help Materials BEHAVIORAL

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.

Oral Screening

Visual Oral Screening Examination PROCEDURE

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

Oral Screening

Direct Fluorescent Oral Visualization Examination PROCEDURE

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

Oral Screening

Oral Biopsy PROCEDURE

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

Oral Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive individuals seeking dental care at Bering Omega/Houston Area Community Services
• Being able to speak English and/or Spanish

You may not qualify if:

• patients under 18 years of age
• patients current participation in a tobacco cessation program
• Patients unwilling or unable to provide consent
• Patients declining oral biopsies

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Baylor College of Medicine: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Bering Omega/Houston Area Community Services

Houston, Texas, 77006, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Biopsy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Irene M. Tami-Maury, DRPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 6, 2016
• Study Start: June 30, 2016
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

US (1)