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Recruiting NCT04622462
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment
Trial Parameters
Condition Oral Neoplasm
Sponsor Proteocyte Diagnostics Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 15 Years
Max Age 90 Years
Start Date 2015-03-12
Completion 2025-12-31
Interventions
Standard of Care HistopathologySTRATICYTE Assessment
Brief 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 Criteria
Inclusion Criteria: * Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia/oral squamous cell carcinoma Exclusion Criteria: * Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy