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Search / Trial NCT04622462

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

Launched by PROTEOCYTE DIAGNOSTICS INC. · Nov 4, 2020

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Leukoplakia Erythroplakia Erythroleukoplakia Lesion Oral Epithelial Dysplasia S100 A7 Biomarker S100 A7 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 Opml Oral Potentially Malignant Disorder Oral Potentially Malignant Lesion

ClinConnect Summary

This clinical trial is looking at a new way to help predict the risk of oral cancer in patients who have suspicious-looking lesions in their mouths. Researchers are using a special test called the S100A7 immunohistochemistry signature-based assessment, or STRATICYTE, to see if it can effectively identify which lesions may develop into cancer. The study aims to find out if this method can help doctors make better decisions about monitoring or treating these lesions early on.

To participate in this trial, you need to have a lesion in your mouth that has been biopsied because doctors want to rule out the possibility of oral cancer. However, if you already have a diagnosis of oral squamous cell carcinoma (a type of mouth cancer), you won't be eligible for this study. If you join, you'll be part of a group that helps researchers understand how to better predict and manage the risk of oral cancer, which could lead to better outcomes for patients in the future.

Gender

ALL

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

About Proteocyte Diagnostics Inc.

Proteocyte Diagnostics Inc. is a leading biotechnology company specializing in the development of innovative diagnostic solutions for the early detection and management of diseases. With a strong focus on precision medicine, the company harnesses advanced technologies and proprietary methodologies to deliver reliable and actionable insights that enhance patient care. Committed to scientific excellence and regulatory compliance, Proteocyte Diagnostics collaborates with healthcare providers and research institutions to drive clinical trials aimed at validating its diagnostic products, ultimately striving to improve health outcomes and transform the landscape of disease management.

Locations

Edmonton, Alberta, Canada

Edmonton, Alberta, Canada

London, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Mark Darling, MSc, MChD

Principal Investigator

Western University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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