NCT06321003 SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
| NCT ID | NCT06321003 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Palermo |
| Condition | Oral Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-13 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-03-13 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Vera Panzarella
PRINCIPAL INVESTIGATOR
University of Palermo
Frequently Asked Questions
Who can join the NCT06321003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Oral Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06321003 currently recruiting?
Yes, NCT06321003 is actively recruiting participants. Contact the research team at vera.panzarella@unipa.it for enrollment information.
Where is the NCT06321003 trial being conducted?
This trial is being conducted at Palermo, Italy.
Who is sponsoring the NCT06321003 clinical trial?
NCT06321003 is sponsored by University of Palermo. The principal investigator is Vera Panzarella at University of Palermo. The trial plans to enroll 200 participants.