NCT04622462

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Proteocyte Diagnostics Inc. · Industry
• Sex: All
• Age: 15 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Oral Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Standard of Care Histopathology	Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer
PROCEDURE	STRATICYTE Assessment	Assessment for risk of progression to oral cancer

Timeline

• Start date: 2015-03-12
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2020-11-10
• Last updated: 2024-11-07

Locations

3 sites across 1 country: Canada