An Early Phase 1 interventional study of Screening Interview and Carbon Monoxide Test in Malignant Neoplasms of Mesothelial and Soft Tissue and Human Immunodeficiency Virus, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-14.
Sponsored by M.D. Anderson Cancer Center · Early Phase 1, Interventional, and Screening
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.
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:
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 44 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
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Exclusion Criteria:
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
Participants asked about demographic information, and questions about history of tobacco, alcohol, and mouthwash use. Interview lasts about 7 minutes.
Carbon monoxide testing given to participants at baseline. Participants blow into a device that measures the amount of carbon monoxide in the lungs.
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.
Intraoral exam performed under incandescent (white light) conditions at baseline, and again two weeks later.
Intraoral exam performed under reduced room lighting with a handheld autofluorescence imaging device at baseline, and again two weeks later.
Premalignant and malignant oral lesions \[PMOL\]) still present 2 weeks after oral exam are biopsied.
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.
Time frame: 2 weeks
Ran from Jun 2016 to primary completion in Jul 2021, 60 months.
Of 46 non-industry phase 1 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's 60 months is above that.
Counting every sponsor, half of 108 studies reached it within 15 months; a quarter within 3 and three quarters within 29.
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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