Using a tiny high-resolution camera and mouth-cell testing to find oral precancer
Official title: Evaluation of Two Non-Invasive Methods, High-Resolution Microendoscopy and Liquid-Based Cytology, for Detection of Oral Precancer
Run by National Institutes of Health Clinical Center (CC) · NCT07260344 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 80 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Taipei, Taipei) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | January 30, 2028 |
| Study ends | January 30, 2029 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07260344 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, these methods could help detect precancer earlier and reduce unnecessary biopsies.
How similar studies have gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.