Track topics on Twitter Track topics that are important to you
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:
- 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Malignant Neoplasms of Mesothelial and Soft Tissue
Screening Interview, Carbon Monoxide Test, Self-Help Materials, Visual Oral Screening Examination, Direct Fluorescent Oral Visualization Examination, Oral Biopsy
Bering Omega/Houston Area Community Services
M.D. Anderson Cancer Center
Published on BioPortfolio: 2016-07-06T23:08:21-0400
The purpose of this study is to evaluate the safety and tolerability of two carbon monoxide doses when administered as an inhaled gas for 1 hour in patients receiving kidney transplants.
Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triag...
Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature co...
The purpose of this study is to determine whether a relationship exists between EtCO2 and carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner relationship ...
To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.
Carbon monoxide is the leading cause of mortality from unintentional poisoning in Slovenia. It has been shown that carbon monoxide levels can rise in wood pellet storerooms because of chemical degrada...
Peripheral neuropathy is a rare complication of carbon monoxide intoxication. Peripheral neuropathy following carbon monoxide intoxication is known to completely recover within a few months.
Carbon monoxide (CO) is both a substance hazardous to health and a side product of a number of industrial processes, such as methanol steam reforming and large-scale oxidation reactions. The separatio...
Carbon monoxide represents the most important C1-building block for the chemical industry, both for the production of bulk and fine chemicals, but also for synthetic fuels. Yet, its toxicity and subse...
Carbon monoxide poisoning is a very common intoxication worldwide. Its clinical manifestations vary from symptoms like mild headache and dizziness to more serious issues including death. Less well kno...
The identification of selected parameters in newborn infants by various tests, examinations, or other procedures. Screening may be performed by clinical or laboratory measures. A screening test is designed to sort out healthy neonates (INFANT, NEWBORN) from those not well, but the screening test is not intended as a diagnostic device, rather instead as epidemiologic.
Toxic asphyxiation due to the displacement of oxygen from oxyhemoglobin by carbon monoxide.
Carbon monoxide (CO). A poisonous colorless, odorless, tasteless gas. It combines with hemoglobin to form carboxyhemoglobin, which has no oxygen carrying capacity. The resultant oxygen deprivation causes headache, dizziness, decreased pulse and respiratory rates, unconsciousness, and death. (From Merck Index, 11th ed)
Tests of accuracy in pronouncing speech sounds, e.g., Iowa Pressure Articulation Test, Deep Test of Articulation, Templin-Darley Tests of Articulation, Goldman-Fristoe Test of Articulation, Screening Speech Articulation Test, Arizona Articulation Proficiency Scale.
Positive test results in subjects who do not possess the attribute for which the test is conducted. The labeling of healthy persons as diseased when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)
Clinical Research Organization
Contract Research Organization (CRO) provide research services outsourced on a contract basis to the pharmaceutical, biotechnology, healthcare and medical device industries: biopharmaceutical development biologic assay development commercial...
Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...
The World Health Organization (WHO) definition of sexual health; "the state of physical, emotional, mental and social well-being related to sexuality; it is not merely the absence of disease, dysfunction and infirmity. Sexual health requires a posit...