Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™

Study Overview
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Brief Summary
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The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.

Detailed Description
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The study objectives are to: Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria. Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model. Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.

Official Title
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Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™

Conditions
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Mouth Diseases

Intervention / Treatment
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* Other: STRATICYTE™ Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: From the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system) Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with: No histological evidence of cancer with clinical follow-up data for a period of at least five years; or OSCC development (histologic or documented evidence of invasive cancer). Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center. Exclusion Criteria: Patients with oral lesions or dysplasia with no indication of OSCC development or follow-up data of less than five years in non-OSCC patients. Patients diagnosed with oral epithelial dysplasia concomitant with OSCC at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| OPMDs that progressed to OSCC<br>No dysplasia, mild, moderate, severe dysplasia, CIS | Other: STRATICYTE™ Test<br>* Assessment for risk of progression to oral cancer<br>* Other names: S100A7 Immunohistochemistry Signature-based Test;|
| OPMDs that did not progress to OSCC<br>No dysplasia, mild, moderate, severe dysplasia, CIS | Other: STRATICYTE™ Test<br>* Assessment for risk of progression to oral cancer<br>* Other names: S100A7 Immunohistochemistry Signature-based Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy | 5 years | 
| Survival analysis | Kaplan-Meier analyses to compare time to a positive diagnosis of oral cancer between patients/biopsies with a STRATICYTE™ classification of Low- and Elevated-Risk. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Area under the receiver operator curve | 5 years | 
| C-index (Harrell's) | From all possible pairs of patients, compute the number of concordant and discordant pairs. Compute C-index as the proportion of all possible pairs that are concordant. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral potentially malignant lesion, Leukoplakia, Erythroplakia, Erythroleukoplakia, Lesion, Oral epithelial dysplasia, S100A7 biomarker, S100A7 Immunohistochemistry Signature-based, Early Diagnosis, STRATICYTE, Oral neoplasia, Oral epithelial atypia, Hyperplasia, Hyperkeratosis, Potentially premalignant oral epithelial lesion, Oral potentially malignant disorders, Mild dysplasia, Moderate dysplasia, Severe dysplasia, Low-grade dyspalsia, High-grade dysplasia, Personalized medicine, Predictive Assay, Whole slide imaging, Computational pathology, Digital pathology