Using a tiny high-resolution camera and mouth-cell testing to find oral precancer
Evaluation of Two Non-Invasive Methods, High-Resolution Microendoscopy and Liquid-Based Cytology, for Detection of Oral Precancer
This project tests whether a high-resolution microendoscope or liquid-based cytology can better find precancer and guide biopsy decisions in people aged 30–80 with visible oral lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Taipei, Taipei) |
| Trial ID | NCT07260344 on ClinicalTrials.gov |
What this trial studies
This is a randomized, cross-sectional study comparing two non-invasive approaches—high-resolution microendoscopy (HRME) and liquid-based oral cytology—against standard clinical impression for triage of visible oral lesions. Patients with visible oral precancerous lesions are randomized to have biopsies guided by either the clinician's examination or HRME, while cytology and clinical impressions are collected for comparison across participants. The main outcomes are histopathologic diagnoses of any dysplasia and high-grade disease (moderate dysplasia or worse). The study is conducted at National Taiwan University Hospital and combines data across arms to compare performance for biopsy triage and lesion detection.
Who should consider this trial
Good fit: Ideal candidates are people aged 30–80 with a visible oral precancerous lesion at least 1 cm in diameter who can give informed consent.
Not a fit: People currently receiving cancer treatment, those who had cancer within the past 12 months, or individuals without visible oral lesions are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, these methods could help detect precancer earlier and reduce unnecessary biopsies.
How similar studies have performed: Similar HRME and cytology techniques have shown promising results for detecting mucosal dysplasia in prior research but have not yet replaced standard biopsy-based diagnosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 30-80 years * Individuals with visible oral precancerous lesions of at 1 cm in greatest diameter Exclusion Criteria: * Individuals who are undergoing current cancer treatment or had a cancer within the last 12 months * Individuals who are unwilling or unable to provide informed consent to participate
Where this trial is running
Taipei, Taipei
- National Taiwan University Hospital — Taipei, Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Anil Chaturvedi, PhD — Division of Cancer Epidemiology and Genetics, National Cancer Institute
- Study coordinator: Kelly Yu, PhD
- Email: yuke@mail.nih.gov
- Phone: 240-276-7041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.