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SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

Recruitingn/aAges 18 Years - 99 YearsAllUniversity of Palermo
NCT06321003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features. The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult patients with clinical suspicion of potentially malignant oral disorders (OPMDs) and oral squamous cell carcinoma (OSCC). 2. Patients able to provide informed consent for participation in the study. 3. Availability of complete clinical data and medical records. Exclusion Criteria: 1. Patients with a previous diagnosis of OSCC/OPMDs and/or who have already undergone treatment. 2. Patients with contraindications to the OCT examination for nonpermissive oral localization using the probe. 3. Pregnant or breastfeeding women. 4. Patients with disabilities, reluctance or difficulties of understanding to follow the procedures of the study and who have not provided a consent.
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What it tests

  • OCT (Optical Coherence Tomography)
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Where

1 site
University of Palermo
Palermo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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