RecruitingNCT04622462

Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment

A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE


Sponsor

Proteocyte Diagnostics Inc.

Enrollment

500 participants

Start Date

Mar 12, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral lesions.


Eligibility

Min Age: 15 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a protein called S100A7 can be used as a marker in tissue biopsies to help identify very early oral cancer or precancerous changes in the mouth before they progress. It is a laboratory/tissue analysis study that does not involve a new treatment. **You may be eligible if...** - You had a biopsy of a suspicious lesion in the mouth to rule out oral cancer or precancerous changes (oral dysplasia) - Biopsy tissue is available for analysis **You may NOT be eligible if...** - Your biopsy showed an existing oral squamous cell carcinoma (established mouth cancer) at the same time as the suspicious lesion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStandard of Care Histopathology

Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer

PROCEDURESTRATICYTE Assessment

Assessment for risk of progression to oral cancer


Locations(3)

Kingsway Oral & Maxillofacial Surgery

Edmonton, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Western University

London, Ontario, Canada

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NCT04622462


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