Recruiting

Oral Cancer

Sponsor:

Proteocyte Diagnostics Inc.

Code:

NCT04622462

Conditions

Oral Neoplasm

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard of Care Histopathology

STRATICYTE Assessment

Study Details

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.

Conditions

Oral Neoplasm

Study ID

NCT04622462

Start date

Mar 12, 2015

Status verified date

Nov, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia

No evidence of dysplasia

Mild dysplasia

Moderate dysplasia

Severe dysplasia

Interventions

Standard of Care Histopathology

Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer

STRATICYTE Assessment

Assessment for risk of progression to oral cancer

Primary outcome measure

  • Malignant Transformation Rate: Dysplasia [ Time Frame: 60 months ]

Central Contacts and Locations

Central contacts

Jason Hwang, PhD

(647) 255-1370jhwang@proteocyte.com

Mark Darling, MSc, MChD

(519) 661-2111mark.darling@schulich.uwo.ca

Locations

Kingsway Oral & Maxillofacial Surgery

Recruiting

Edmonton, Alberta, Canada, T5M 3Z7

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 1C9

Western University

Recruiting

London, Ontario, Canada, N6A 5C1

More Information

Sponsor

Proteocyte Diagnostics Inc.

Last update posted

Nov 7, 2024

Last verified

Nov, 2024

Keywords

  • Leukoplakia
  • Erythroplakia
  • Erythroleukoplakia
  • Lesion
  • 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
  • OPML
  • Oral Potentially Malignant Disorder
  • Oral Potentially Malignant Lesion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Proteocyte Diagnostics Inc. on 2024-11-07.