An interventional study of Deep UV-M and AI Cytology Triage in Oral Potentially Malignant Lesions, Oral Potentially Malignant Disorders and Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, sponsored by Anh Le. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Anh Le · Not applicable, Interventional, and Diagnostic
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Among 191 studies in Mouth Neoplasms with a site in United States — 50 open to participants now, 70 under way, 4 of them phase 3. Mouth Neoplasms · United States.
Among the 191 studies in Mouth Neoplasms with a site in United States, this one is the 22nd largest by planned enrollment of the 149 interventional ones that give a count, is one of 11 that started in 2026, is one of 44 with no phase, reaches primary completion later than 49 of the 69 other live ones, and was the 190th registered.
447 studies on the registry are indexed under Mouth Neoplasms; 131 are open to participants now.
Browse Mouth Neoplasms studies →50 of the 191 studies in Mouth Neoplasms with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Metaclipse Therapeutics Corporation · Sites in United States
Ages 18+
OHSU Knight Cancer Institute · Sites in United States
Ages 18–89
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 97 Mouth Neoplasms studies recruiting now, 58 (60%) set no upper age limit and 23 (24%) stop at 75 or younger; 5 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
191 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 70 · Phase 3 11 · Phase 4 4
First in 1992; this study’s year is marked. 11 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 270 is above the median of 60 across 313 interventional studies indexed under Mouth Neoplasms.
Median enrollment 46 across the 149 interventional studies, 86 across the 32 observational. Of the 113 that completed or were terminated, 41 (36%) have results posted.
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20 of 191 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Anh Le as lead sponsor.
Anh Le has 1 study filed under Mouth Neoplasms — fewer than ten, so there is no comparison to draw.
25 of the studies in Mouth Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05837221University of Colorado, DenverMicrobiome in Head and Neck Squamous Cell Carcinoma | 2026-11 |
| NCT05312710Aveta Biomics, Inc.Safety and Efficacy of APG-157 in Head and Neck Cancer | 2026-12 |
| NCT05451303ViomeDetection of Oral and Throat Cancers Using OralViome Cancer Testing System | 2026-12 |
| NCT06174428ViomeValidity of Viome's Oral/throat Cancer Test | 2026-12 |
| NCT04870762M.D. Anderson Cancer CenterCustomized 3D Printed Oral Stents During Head and Neck Radiotherapy | 2026-12-31 |
Add all 25 to your calendar (.ics) → With an account.
Among the 191 studies in Mouth Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
This research project establishes a new diagnostic paradigm by transforming oral brush cytology from a centralized, laboratory-dependent procedure into an automated, AI-assisted point-of-care (POC) triage system. Traditional brush cytology relies on chemical staining, physical sample shipping, and off-site expert review, which can introduce diagnostic turnaround delays. By combining label-free optical imaging with automated hardware and deep learning, this system aims to deliver immediate, same-visit triage of suspicious oral lesions directly within primary dental and outpatient clinics.
Optical Physics \& Optomechanical Engineering: The core imaging system utilizes Deep Ultraviolet (DUV) microscopy operating in the 200-280 nm spectral range. At these wavelengths, cellular nucleic acids and proteins exhibit strong intrinsic light absorption, enabling submicron-resolution, high-contrast visualization of nuclear architecture without chemical dyes or fluorescent stains.
Transformer-Based AI Framework (CellViT): Cellular analysis and classification are powered by an adapted CellViT deep learning framework, which replaces traditional object-detection architectures like YOLOv7.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with suspicious oral lesions undergo a quick, non-invasive oral brush test analyzed in real time by the experimental Deep UV AI platform. Immediately after, participants receive the routine 5 mm tissue biopsy to confirm their diagnosis. The AI scan result is compared directly against the biopsy pathology to measure the AI's diagnostic accuracy.
Device: Deep UV-M and AI Cytology Triage
Non-invasive oral brush cytology harvests full-thickness epithelial cells from suspicious lesions. Cells are smeared onto UV glass slides and fixed in 95% ethanol. Unstained slides are scanned on a point-of-care Deep UV Microscope (DUV-M). An adapted AI model performs per-cell instance segmentation, extracts nuclear morphometric features, and delivers a binary triage result (non-dysplasia vs. dysplasia/cancer).
Triage Classification
The primary endpoint is the accurate binary triage classification (distinguishing non-dysplasia from dysplasia/cancer) performed by the AI DUV-M platform, compared against the reference standard of histopathology.
Time frame: From the time of oral brush cytology sampling on Day 1 through completion of the reference biopsy histopathology report, assessed up to 14 days post-procedure.
Three-Class Diagnostic Discrimination
While the primary endpoint focuses on binary triage (non-dysplasia vs. dysplasia/cancer), the secondary analysis evaluates the AI framework's ability to discriminate samples across three distinct diagnostic categories: non-dysplasia, dysplasia, and invasive cancer.
Time frame: From sample collection on Day 1 through completion of 3-class histopathological grading, assessed up to 14 days post-procedure.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 98 non-industry interventional studies with no phase under Mouth Neoplasms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 97. This study's planned 24 months is below that.
Counting every sponsor, half of 99 studies reached it within 30 months; a quarter within 17 and three quarters within 107.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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