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Clinical Trials

MainTitle

Non Invasive Oral Cancer Screening Among HIV Infected Individuals

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2017 by M.D. Anderson Cancer Center

Sponsor
M.D. Anderson Cancer Center

Collaborator
Baylor College of Medicine
The University of Texas Health Science Center, Houston

Information provided by (Responsible Party)
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier
NCT02823847

First received: July 1, 2016
Last updated: January 3, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Malignant Neoplasms of Mesothelial and Soft Tissue
Human Immunodeficiency Virus

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
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Non-invasive Oral Cancer Screening Among Individuals Who Have HIV Infection

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures

  • Positive Predictive Value for Premalignant and Malignant oral lesions (PMOL) [ Time Frame: 2 weeks ]
    Positive predictive value defined as the number of true positives (confirmed PMOLs) divided by the total number of suspicious lesions.

Estimated Enrollment: 80
Study Start Date: July 2016
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Oral Screening
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

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.

Detailed Description:

If you agree to take part in this study, you will be asked to come to the clinic for 2 study visits.
First Study Visit:

  • You will be asked questions about your history of tobacco, alcohol, and mouthwash use. You will also be asked questions about your demographic information (such as age, sex at birth, sexual orientation and gender identification, educational level, and insurance status). This interview will last about 7 minutes.
  • You will be asked to blow into a device that measures the amount of carbon monoxide in your lungs. Smokers may have a larger amount of carbon monoxide in their lungs.
  • You will be given referral information for a tobacco cessation program if you want help
to stop smoking.
After this first interview, you will have a standard dental exam of your mouth and throat using normal office lighting. Any suspected PMOLs will be photographed. Right after that, a second dental exam will be performed, using a hand-held fluorescent light device. This device will be shined into your mouth to help the doctor check for PMOLs. Any suspected PMOLs will be photographed under the fluorescent light.
Second Study Visit (Follow-up):
About 2 weeks after your first study visit, you will be asked to return to the clinic. During this visit, you will have another oral exam with both standard and fluorescent light. You will also be asked 3 questions about being enrolled in any tobacco cessation programs. If any PMOL(s) that were found during the first visit are is still present, the study staff will collect a biopsy of the PMOL tissue. The type of biopsy you have will depend on the number of PMOLs you have and their location, size, shape, and appearance. To perform this biopsy, the affected area is removed by cutting it out (possibly completely). Local anesthesia will be used. The biopsied tissue samples will be sent to the laboratory for routine testing. The results of the biopsies will be used to test the accuracy of the 2 oral exams.
A dental appointment will be made with you about 7-14 days after the oral biopsy to inspect the wound and discuss the biopsy result.
Length of Study:
Your active study participation will be over after the second study visit.
This is an investigational study. The standard oral exams are performed using FDA-approved and commercially available methods. The use of the fluorescent light is considered investigational.
The performance of the PMOL follow-up biopsy is considered standard of care.
Up to 80 participants will be enrolled in this research study. All will be enrolled at Bering Omega Community Services Dental Clinic.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02823847

Contacts

Contact:   Irene M. Tami-Maury, DRPH 713-563-1264

Locations

United States, Texas
Bering Omega/Houston Area Community Services Recruiting
Houston, Texas, United States, 77006

Sponsors and Collaborators

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

Investigators

Principal Investigator: Irene M. Tami-Maury, DRPH M.D. Anderson Cancer Center
More Information

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website

Responsible Party: M.D. Anderson Cancer Center  
ClinicalTrials.gov Identifier: NCT02823847   History of Changes  
Other Study ID Numbers: 2015-1030  
Study First Received: July 1, 2016  
Last Updated: January 3, 2017  

Keywords provided by M.D. Anderson Cancer Center:

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

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Neoplasms
Mouth Neoplasms
Carbon Monoxide

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.