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Study identifier: NCT06321003 Synced from ClinicalTrials.gov · July 28, 2026
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SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

Condition: Oral Squamous Cell Carcinoma · Oral Potentially Malignant Disorder · Oral Leukoplakia  ·  Sponsor: University of Palermo

PhaseN/A
Planned participants200
Who can joinAll sexes, 18 Years to 99 Years
Healthy volunteersNo

About this study

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 patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC. Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods. In summary, the …

This description comes directly from the study's public registry record.

Talk to the study team

Vera Panzarella  ·  091 6554612  ·  vera.panzarella@unipa.it

Always discuss trial participation with your own doctor first.

Locations (1)

University of PalermoPalermo, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06321003