Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02823847 |
| Other study ID # |
2015-1030 |
| Secondary ID |
NCI-2016-01073 |
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2016 |
| Est. completion date |
July 26, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
