NCT07249437

Non-invasive Methods for Oral Cancer Screening

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Oral cancer is a common cancer worldwide, with approximately 250,000 new cases annually and a high mortality rate. Its major risk factors include smoking, alcohol consumption, and betel nut chewing. Current screening methods rely heavily on visual inspection by specialist physicians and invasive biopsy of lesions, but they suffer from limitations such as insufficient sensitivity, sampling errors in biopsies, and low patient compliance. This study proposes an innovative cross-sectional randomized trial aimed at evaluating two non-invasive techniques-oral digital imaging photography (high-resolution microendoscopy, HRME) and liquid-based cytology (LBC) of the oral mucosa-in order to optimize the screening of oral precancerous lesions.

Detailed description

Oral cancer is a common malignancy worldwide, with approximately 250,000 new cases diagnosed annually and a high mortality rate. Its primary risk factors are smoking, alcohol consumption, and betel nut chewing. Current screening methods heavily rely on visual inspection by specialist physicians and invasive biopsy of lesions, but they are limited by insufficient sensitivity, biopsy sampling errors, and low patient compliance. To address these issues, this study proposes an innovative cross-sectional randomized trial to evaluate two non-invasive techniques-high-resolution microendoscopy (HRME) and liquid-based cytology (LBC) of the oral mucosa-with the aim of optimizing screening for oral precancerous lesions. The study will recruit 400 participants with visually identified oral potentially malignant disorders (e.g., leukoplakia or erythroplakia) and randomly assign them to two groups: a clinical biopsy group (biopsy site selected based on conventional visual inspection), and an HRME-guided biopsy group (biopsy site directed by high-resolution microendoscopy). Both groups will also undergo liquid-based cytology (LBC) through collection and analysis of oral mucosal cells. The study objectives include: Comparing the detection rates of precancerous lesions (mild, moderate, severe dysplasia, or carcinoma in situ, or invasive cancer) between the two groups; Analyzing the intra-lesional consistency of biopsy sites in both groups; Validating the diagnostic performance of LBC alone or in combination with HRME.

Conditions

• Oral Cancer Screening

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: Taiwan