Clinical Research Directory

Feasibility and Validation of an Automated AI-Enabled Deep Ultraviolet (DUV) Cytology Platform for Point-of-Care Oral Cancer Triage

This research study evaluates an experimental, point-of-care tool that combines Deep Ultraviolet (DUV) light imaging with Artificial Intelligence (AI) to rapidly screen for oral cancer and pre-cancer (dysplasia). The main goal is to determine if this automated tool can accurately deliver immediate, same-visit triage results (categorizing cells as either non-dysplasia or dysplasia/cancer) without needing chemical stains, sample transport, or off-site laboratory processing. The following occurs during a singular clinic visit for participants: 1. Minimally Invasive Brush Test: A clinician gently rotates a soft brush over the mouth tissue to collect surface cells. 2. Stain-Free Imaging \& AI Analysis: The DUV microscope scans the unstained cells in minutes, and the AI analyzes cell features (such as nucleus size and shape) in under 10 seconds. 3. Standard Medical Care: Participants with suspicious spots receive a standard tissue biopsy to ensure a definitive, confirmed diagnosis regardless of the AI result. This is important given that the five-year survival rates for oral cancer exceed 80% when caught early but drop to under 20% if detected late. By delivering rapid results directly at the clinic, this technology aims to eliminate long waiting periods for lab results, accelerate specialist referrals, and improve access to early screening in community dental and medical clinics.

Effects of a Perma-h Model Mobile-based Rehabilitation Support Program on Hope, Self-efficacy, Perceived Social Support and Rehabilitation Outcomes in Post- Tracheostomy Oral Cancer Patients

The goal of this study (exploratory sequential design; mixed-methods study) is to evaluate whether a PERMA-H model mobile-based rehabilitation support program delivered to post-tracheostomy oral cancer patients can improve psychological and rehabilitation outcomes, compared with a control group receiving usual care/standard support. The study will focus on post-tracheostomy oral squamous cell carcinoma (OSCC) patients (aged ≥18 years) who are undergoing or scheduled to undergo tracheostomy followed by decannulation, and who have adequate communication ability and caregiver support. The main questions it aims to answer are: Does the PERMA-H model mobile-based rehabilitation support program improve patients' hope? (primary hypothesis/outcome measure 1) Does the PERMA-H model mobile-based rehabilitation support program improve patients' self-efficacy, perceived social support, and rehabilitation outcomes? (primary hypothesis/outcome measure 2) If there is a comparison group, researchers will compare the PERMA-H model mobile-based rehabilitation support program (intervention group) to a control group receiving standard/usual care (control group) to determine differences in outcomes between groups. Participants will be asked to complete the main study tasks, including: participating in qualitative interviews to explore their digital needs, expectations, and experiences regarding psychosocial care (Phase I); using the WeChat mini-program platform that incorporates a PERMA-H evidence-based module set and a chatbot (Decannulationbot / Digital rehabilitation Assistant, DDA) as part of the rehabilitation support program; completing validated assessments at study endpoints to measure hope (Herth Hope Index), self-efficacy (General Self-Efficacy Scale), and perceived social support (Perceived Social Support Scale), as well as rehabilitation-related outcomes (including rehabilitation willingness/participation and functional measures such as swallowing function and speech intelligibility as rated by speech-language pathologists). Expected outcomes include: comprehensive qualitative findings to inform the content and delivery of digital psychosocial support; a functional mobile intervention platform with evidence-based modules validated through expert appraisal and pilot testing; and statistically significant improvements in hope, self-efficacy, perceived social support, and rehabilitation outcomes in the intervention group compared with the control group.

The Importance of Mucosal Screening in the Prevention of Oral Cancer.

Patients attending the Department of Oral Mucosal and Periodontal Diseases at the University Dental Center of the Medical University of Warsaw who provide written informed consent will be invited to participate in the study. Participation will begin with completing a short, anonymous questionnaire. The questions will focus on factors that may increase the risk of developing oral potentially malignant disorders and oral cancer, such as tobacco use, alcohol consumption, dietary habits, chronic diseases, and other health-related information. Next, a comprehensive oral examination will be performed by a qualified dental hygienist according to a standardized examination protocol. The examination will include assessment of the lips, cheeks, gums, hard and soft palate, tongue, floor of the mouth, and throat. The oral mucosa will be evaluated for its appearance, colour, moisture, and the presence of any abnormalities, such as white or red patches, ulcers, erosions, nodules, or other lesions. A palpation examination of selected lymph nodes in the head and neck region will also be performed. During the visit, oral hygiene will be assessed using an oral hygiene index. The condition of the teeth and any prosthetic restorations will also be evaluated to identify areas where dental plaque may accumulate or where chronic irritation of the oral mucosa may occur. The final stage of the examination will involve assessment of the oral mucosa using the Oralitest fluorescence device. This is a painless, non-invasive procedure that uses light of a specific wavelength to examine the oral mucosa. The examination takes only a few minutes, requires no special preparation, and the device does not come into direct contact with the oral tissues. Healthy oral mucosa emits a characteristic green fluorescence, whereas areas that may require further investigation appear as darker regions. The result of the fluorescence examination is available immediately after the procedure.

Enhancing Oral Cancer Awareness

To evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on increasing participants' knowledge of oral cancer and its prevention

Proactive Risk-based Optimization & Notifications for Treatment & Outcomes in Head & Neck Cancer

Delays between surgery and the initiation of post-operative radiotherapy (S-PORT) in head and neck cancer (HNC) patients are prevalent and associated with worse oncologic outcomes. This pilot study evaluates whether a proactive, automated care coordination system (PRONTO-HN) can improve adherence to recommended S-PORT intervals of ≤42 days at the Centre hospitalier de l'Université de Montréal (CHUM). The study is a single-center, quasi-experimental, interrupted time-series design with two phases. Group A (control) includes patients treated before the intervention (using a prospectively maintained database from August 2024 to August 2025). Group B (intervention) includes patients treated with the new coordination system from September 2025 to September 2026. The intervention includes automated alerts, multidisciplinary task coordination, and risk stratification based on a predictive model developed and published by our team. This model uses only pre-operative data to estimate the likelihood that a patient will require adjuvant therapy after surgery, stratifying patients into high- and low-risk categories. High-risk patients receive intensified coordination protocols, including early oncology and dental consultations and shorter target times for pathology results. Primary objective: Reduce the proportion of patients with S-PORT \> 42 days. Secondary/tertiary objectives: Reduce mean S-PORT time. Evaluate impacts on overall, locoregional, and disease-free survival in a 2- and 3-year follow up study. Patients are identified at the time the operating room request is submitted. Demographic, clinical, and oncologic data are collected and stored securely in REDCap. As the intervention is administrative in nature and does not modify patient care, consent is waived. Statistical analysis will evaluate the intervention's effect and identify predictors of delays. A sample of 38 patients per group provides adequate power to detect a drop in S-PORT \> 42 days from 80% to 50%.