Non Invasive Oral Cancer Screening Among HIV Infected Individuals
NCT ID: NCT02823847
Last Updated: 2022-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
44 participants
INTERVENTIONAL
2016-06-30
2021-07-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
NCT00004781
Assessing HIV-Related Oral Mucosal Disease and Using Saliva to Measure Viral Load
NCT00959413
The Impact of Oral Health in HIV Patients on Antiretroviral Therapy
NCT04645693
The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV
NCT06205511
Screening for HIV-Associated Anal Cancer
NCT00188292
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Screening Interview
Participants asked about demographic information, and questions about history of tobacco, alcohol, and mouthwash use. Interview lasts about 7 minutes.
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.
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.
Visual Oral Screening Examination
Intraoral exam performed under incandescent (white light) conditions at baseline, and again two weeks later.
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.
Oral Biopsy
Premalignant and malignant oral lesions \[PMOL\]) still present 2 weeks after oral exam are biopsied.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Screening Interview
Participants asked about demographic information, and questions about history of tobacco, alcohol, and mouthwash use. Interview lasts about 7 minutes.
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.
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.
Visual Oral Screening Examination
Intraoral exam performed under incandescent (white light) conditions at baseline, and again two weeks later.
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.
Oral Biopsy
Premalignant and malignant oral lesions \[PMOL\]) still present 2 weeks after oral exam are biopsied.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Being able to speak English and/or Spanish
Exclusion Criteria
2. patients current participation in a tobacco cessation program
3. Patients unwilling or unable to provide consent
4. Patients declining oral biopsies
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Baylor College of Medicine
OTHER
The University of Texas Health Science Center, Houston
OTHER
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Irene M. Tami-Maury, DRPH
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bering Omega/Houston Area Community Services
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
University of Texas MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-01073
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-1030
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.