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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00540774
Other study ID # 20022805
Secondary ID R44CA265514T31IR
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2003
Est. completion date December 2028

Study information

Verified date April 2024
Source University of California, Irvine
Contact Nicole Wakida, PhD
Phone 949-824-4360
Email nwakida@uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and optical approaches. All different areas of the mouth will be imaged, including healthy, diseased, dysplastic and malignant, as well as oral biofilm, and the imaging data compared against conventional diagnostic approaches such clinical and histopathological and molecular evaluations to (1) gain a better understanding of processes involved in oral pathology and (2) develop a combined patient specific, non-invasive method for the detection, diagnosis and screening of oral pathology and biofilm. Thus our goal is to identify and evaluate microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia. We are recruiting patients with a wide range of oral conditions including plaque, dry mouth, toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune conditions and others as well as healthy control subjects. We will use a range of non-invasive imaging modalities to obtain information on the ways in which the oral health status affects optical properties, and determine means of detecting and quantifying these factors.. Imaging modalities to be utilized include: 1. Coherence and Doppler Tomography 2. Laser Speckle Imaging 3. Various forms of Spectroscopy 4. Fluorescence


Description:

Purpose of the research is to identify optical predictors and biomarkers of health and disease. Hypothesis: microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia. Researchers of the Beckman Laser Institute (BLI) have developed many non-invasive imaging modalities for assessment of oral tissue. This protocol will allow data acquisition with these multiple modalities to allow validation of data. Imaging modalities to be utilized include: 1. Coherence and Doppler Tomography (OCT) 2. Laser Speckle Imaging (LSI) 3. Photon Migration Spectroscopy (PMS) 4. Autofluorescence Imaging In addition, saliva samples from the patients will be analyzed and the resulting data regarding the dysregulation in the activities of genes, proteins and other molecules will be correlated with findings from different imaging systems with respect to the stage of oral carcinogenesis.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Male or Female age 18 years and older - Have oral lesion or not have oral lesion - Have condition of dry mouth - Have condition of Gum disease - Non-smoker Exclusion Criteria: - Age less than 18 years old - Advanced gum disease, diseases of oral tissue - Untreated cavities - Pregnant or breastfeeding - Immune compromised individuals

Study Design


Related Conditions & MeSH terms


Intervention

Device:
detection of oral pathology
detection of oral pathology

Locations

Country Name City State
United States Beckman Laser Institute and Medical Clinic Irvine California

Sponsors (7)

Lead Sponsor Collaborator
University of California, Irvine Livionex Inc., National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), Orahealth

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healthy oral tissue Develop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology up to 12 months
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