Malignant Neoplasms of Mesothelial and Soft TissueEarly Phase 1NCT02823847
Non Invasive Oral Cancer Screening Among HIV Infected Individuals
A Early Phase 1 study testing Screening Interview, Carbon Monoxide Test and Self-Help Materials in people with Malignant Neoplasms of Mesothelial and Soft Tissue and Human Immunodeficiency Virus, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Mesothelial and Soft Tissue, Human Immunodeficiency Virus
- What is being tested?
- Screening Interview, Carbon Monoxide Test and Self-Help Materials
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 26 Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive individuals seeking dental care at Bering Omega/Houston Area Community Services
- Being able to speak English and/or Spanish
Who cannot join
- patients under 18 years of age
- patients current participation in a tobacco cessation program
- Patients unwilling or unable to provide consent
- Patients declining oral biopsies
Trial locations and contacts
1 site in 1 country.
United States1 site
Bering Omega/Houston Area Community Services
Houston, Texas, 77006
About this study
Official title: Non-invasive Oral Cancer Screening Among Individuals Who Have HIV Infection
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.
Read the 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.
- Being tested
- Screening Interview, Carbon Monoxide Test, Self-Help Materials, Visual Oral Screening Examination, Direct Fluorescent Oral Visualization Examination
- 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening InterviewBehavioural
Participants asked about demographic information, and questions about history of tobacco, alcohol, and mouthwash use. Interview lasts about 7 minutes.
Carbon Monoxide TestDevice
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 MaterialsBehavioural
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 ExaminationProcedure or surgery
Intraoral exam performed under incandescent (white light) conditions at baseline, and again two weeks later.
Direct Fluorescent Oral Visualization ExaminationProcedure or surgery
Intraoral exam performed under reduced room lighting with a handheld autofluorescence imaging device at baseline, and again two weeks later.
Oral BiopsyProcedure or surgery
Premalignant and malignant oral lesions [PMOL]) still present 2 weeks after oral exam are biopsied.
| Study group | Role | What they receive |
|---|---|---|
| Oral Screening | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start30 Jun 2016
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Mesothelial and Soft TissueStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene M. Tami-Maury, DRPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823847
- Sponsor's protocol ID
- 2015-1030
- Other IDs
- NCI-2016-01073
- Status last verified
- Feb 2022
- First submitted
- 1 Jul 2016
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Oral Cancer Screening Among Individuals Who Have HIV Infection
- ClinicalTrials.gov ID
- NCT02823847
- Acronym / sponsor ID
- 2015-1030
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, The University of Texas Health Science Center, Houston
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Screening | Experimental | Behavioral: Screening Interview, Device: Carbon Monoxide Test, Behavioral: Self-Help Materials, Procedure: Visual Oral Screening Examination, Procedure: Direct Fluorescent Oral Visualization Examination, Procedure: Oral BiopsyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV positive individuals seeking dental care at Bering Omega/Houston Area Community Services
- Being able to speak English and/or Spanish
Key exclusion criteria (4 listed)
- patients under 18 years of age
- patients current participation in a tobacco cessation program
- Patients unwilling or unable to provide consent
- Patients declining oral biopsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening InterviewParticipants asked about demographic information, and questions about history of tobacco, alcohol, and mouthwash use. Interview lasts about 7 minutes. | Behavioural | Oral Screening |
| Carbon Monoxide TestCarbon monoxide testing given to participants at baseline. Participants blow into a device that measures the amount of carbon monoxide in the lungs. | Device | Oral Screening |
| Self-Help MaterialsParticipants 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. | Behavioural | Oral Screening |
| Visual Oral Screening ExaminationIntraoral exam performed under incandescent (white light) conditions at baseline, and again two weeks later. | Procedure or surgery | Oral Screening |
| Direct Fluorescent Oral Visualization ExaminationIntraoral exam performed under reduced room lighting with a handheld autofluorescence imaging device at baseline, and again two weeks later. | Procedure or surgery | Oral Screening |
| Oral BiopsyPremalignant and malignant oral lesions [PMOL]) still present 2 weeks after oral exam are biopsied. | Procedure or surgery | Oral Screening |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene M. Tami-Maury, DRPH principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Screening Interview, Carbon Monoxide Test and Self-Help Materials in people with Malignant Neoplasms of Mesothelial and Soft Tissue and Human Immunodeficiency Virus, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value for Premalignant and Malignant oral lesions (PMOL) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.