Brief Summary

This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

338

participants targeted

Target at P75+ for not_applicable

Timeline

12mo left

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

19.7 years study duration

Study Progress95%

Aug 2007Apr 2027

Study Start

First participant enrolled

August 27, 2007

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed

19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

19.7 years

First QC Date

October 10, 2007

Last Update Submit

March 3, 2026

Conditions

Erythroplakia Fanconi Anemia Lichen Planus Oral Cavity and Lip Precancerous Condition Oral Cavity Leukoplakia Oral Neoplasm Premalignant Lesion Tobacco Use Disorder

Outcome Measures

Primary Outcomes (3)

Lesions diagnosed via wide-field fluorescence imaging
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Up to 10 years
Lesions diagnosed via point spectroscopy system
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Up to 10 years
Lesions diagnosed via non-invasive brush cytology
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Up to 10 years

Study Arms (1)

Diagnostic (fluorescent/reflectance imaging, spectroscopy)

EXPERIMENTAL

Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.

Other: Cytology Specimen Collection ProcedureProcedure: Diagnostic MicroscopyProcedure: Diagnostic ProcedureProcedure: Fluorescence ImagingProcedure: Fluorescence Spectroscopy