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

Recruiting

• Conditions: Oral Neoplasm
• Interventions: Procedure: Standard of Care Histopathology; Procedure: STRATICYTE Assessment

• Registration Number: NCT04622462
• Lead Sponsor: Proteocyte Diagnostics Inc.

Brief 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).

Study Timeline

• Study Start: 2015-03-12
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia	STRATICYTE Assessment	No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia
Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia	Standard of Care Histopathology	No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia

Primary Outcome Measures

Name	Time	Method
Malignant Transformation Rate: Dysplasia	60 months	Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk

Secondary Outcome Measures

Name	Time	Method
Malignant Transformation Rate: No Dysplasia	60 months	Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk
Recurrence Rate	60 months	Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Trial Locations

Locations (3)

Kingsway Oral & Maxillofacial Surgery; 🇨🇦 Edmonton, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Western University; 🇨🇦 London, Ontario, Canada