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
Inclusion Criteria1
- Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia/oral squamous cell carcinoma
Exclusion Criteria1
- Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy
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)
View Full Details on ClinicalTrials.gov
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NCT04622462