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Trial record 12 of 126 for:    "Viral Infectious Disease" | "Ethanol"

Non Invasive Oral Cancer Screening Among HIV Infected Individuals

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ClinicalTrials.gov Identifier: NCT02823847
Recruitment Status : Active, not recruiting
First Posted : July 6, 2016
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Baylor College of Medicine
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment 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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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
Actual Study Start Date : June 30, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823847


Locations
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United States, Texas
Bering Omega/Houston Area Community Services
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
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Principal Investigator: Irene M. Tami-Maury, DRPH M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02823847     History of Changes
Other Study ID Numbers: 2015-1030
NCI-2016-01073 ( Registry Identifier: NCI CTRP )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
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:
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RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Acquired Immunodeficiency Syndrome
HIV Infections
Mouth Neoplasms
Immunologic Deficiency Syndromes
Neoplasms
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs