Clinical trial NCT02823847: Non Invasive Oral Cancer Screening Among HIV Infected Individuals
Official title: Non-invasive Oral Cancer Screening Among Individuals Who Have HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
name: The University of Texas Health Science Center, Houston
First posted: 2016-07-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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 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

Primary outcomes:
measure: Positive Predictive Value for Premalignant and Malignant oral lesions (PMOL)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Bering Omega/Houston Area Community Services
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Irene M. Tami-Maury, DRPH
role: PRINCIPAL_INVESTIGATOR
References: