Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06321003 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: SYMILIS OCT
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study completion date: Apr 1, 2027 to Apr 1, 2028v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.
Trial Details
NCT Number NCT06321003
Lead Sponsor University of Palermo
Conditions
(from sponsor)
Oral Squamous Cell Carcinoma, Oral Potentially Malignant Disorder, Oral Leukoplakia, Proliferative Verrucous Leukoplakia, Oral Lichen Planus, Oral Lichenoid Lesion, Graft-versus-host-disease, Oral Erythroplakia +4 more
Related terms Actinic cheilitis, Graft vs Host Disease, Keratosis, Actinic, Leukoplakia, Oral, Lichen Planus, Oral, Mouth Diseases, Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov