Spots Global Cancer Trial Database for Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™
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Trial Identification
Brief Title: Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™
Official Title: Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™
Study ID: NCT05853783
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.
Detailed Description: The study objectives are to: 1. Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria. 2. Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model. 3. Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Alabama at Birmingham, Birmingham, Alabama, United States
Loma Linda University, Loma Linda, California, United States
Minnesota Oral and Facial Surgery, Minneapolis, Minnesota, United States
MD Anderson Cancer Cetner, Houston, Texas, United States
UTHealth Houston School of Dentistry, Houston, Texas, United States
Contact Details
Name: Simon W Young, DDS, MD, PhD
Affiliation: UTHealthHouston
Role: PRINCIPAL_INVESTIGATOR
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