Trials Sponsors Conditions Drugs Pricing

Conditions

Oral Cancer Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer Oral Potentially Malignant Disorders Oral Potentially Malignant Lesions

Keywords

oral canceroral squamous cell carcinomaoral cavity canceroral potentially malignant lesions

Outcome Measures

Primary Outcomes (1)

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.
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.

Secondary Outcomes (1)

Three-Class Diagnostic Discrimination
From sample collection on Day 1 through completion of 3-class histopathological grading, assessed up to 14 days post-procedure.

Study Arms (1)

AI-Enabled Deep UV Brush Cytology with Biopsy Validation

EXPERIMENTAL

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

Interventions

Deep UV-M and AI Cytology TriageDevice

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).

AI-Enabled Deep UV Brush Cytology with Biopsy Validation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Suspicious Lesions Cohort: Adults with suspicious oral potentially malignant lesions (OPML), such as leukoplakia, erythroplakia, or speckled lesions), oral precancer (dysplasia), or suspected oral/oropharyngeal squamous cell carcinoma (OSCC) who are scheduled for a diagnostic incisional or excisional tissue punch biopsy.

Sponsors & Collaborators

Anh Le
Otherlead
University of Arizona
Othercollaborator

Study Sites (1)

University of Pennsylvania, Department of Oral & Maxillofacial Surgery/Pharmacology

Philadelphia, Pennsylvania, 19104, United States

Annachristine HooverCONTACT310-560-7767 annachristine.hoover@pennmedicine.upenn.edu

Anh Le, DDS, PhDCONTACT215-662-6176 anh.le@pennmedicine.upenn.edu

MeSH Terms

Conditions

Mouth NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

Anh D Le, DDS, PhD
University of Pennsylvania
PRINCIPAL INVESTIGATOR

Central Study Contacts

Annachristine Hoover

CONTACT

310-560-7767 annachristine.hoover@pennmedicine.upenn.edu

Anh D Le, DDS, PhD

CONTACT

215-662-6176

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Norman Vine Endowed Professor and Department Chair

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 25, 2026

Study Start

December 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 2028

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

AI-Enabled Deep UV Brush Cytology with Biopsy Validation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

AI-Enabled Deep UV Brush Cytology with Biopsy Validation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations