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

Study Overview
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Brief Summary
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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.

Detailed Description
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Background: The standard of care for potentially premalignant oral epithelial lesion (PPOEL) risk assessment for progression to cancer is dysplasia grading by histopathology. With significant overlap between dysplasia grades and high inter- and intra-observer variations, dysplasia grading alone has been shown to be inadequate as a prognostic tool. To investigate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in the early diagnosis of invasive oral cancer, a prospective multi-center observational study was designed with specimens obtained from community-based practices. Methods: Patients that qualify to enroll in the study will be assessed for both standard of care histopathological assessment for dysplasia grade and STRATICYTE risk assessment, and followed for up to 60 months (from initial biopsy) to determine the outcome of their oral lesion(s).

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

Conditions
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Oral Neoplasm

Intervention / Treatment
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* Procedure: Standard of Care Histopathology
* Procedure: STRATICYTE Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia<br>No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia | Procedure: Standard of Care Histopathology<br>* Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer<br>* Other names: H&E assessment for dysplasia grade;Procedure: STRATICYTE Assessment<br>* Assessment for risk of progression to oral cancer<br>* Other names: S100A7 Immunohistochemistry Signature-based Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malignant Transformation Rate: Dysplasia | Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malignant Transformation Rate: No Dysplasia | Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk | 60 months | 
| Recurrence Rate | Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lesion, OPML, Leukoplakia, Erythroplakia, Erythroleukoplakia, Oral Epithelial Dysplasia, S100A7 Biomarker, S100A7 Immunohistochemistry Signature-based, Early Diagnosis, STRATICYTE, Oral Neoplasia, Oral Epithelial Atypia, Hyperplasia, Hyperkeratosis, Oral Squamous Cell Carcinoma, Oral Cancer, Potentially Premalignant Oral Epithelial Lesion, OPMD, Mild Dysplasia, Moderate Dysplasia, Severe Dysplasia, Low-grade Dysplasia, High-grade Dysplasia, Personalized Medicine, Predictive Assay, Whole Slide Imaging, Computational Pathology, Digital Pathology, Artificial Intelligence, Machine Learning, Oral Potentially Malignant Disorder, Oral Potentially Malignant Lesion