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

NCT04622462 | Recruiting

• 1 other identifier: PRO-STR-PPOEL-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (1)

• Malignant Transformation Rate: Dysplasia

  Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk

  60 months

Secondary Outcomes (2)

• Malignant Transformation Rate: No Dysplasia

  60 months

• Recurrence Rate

  60 months

Study Arms (1)

Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia

No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia

Procedure: Standard of Care Histopathology; Procedure: STRATICYTE Assessment

Interventions

Standard of Care Histopathology PROCEDURE

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

Also known as: H&E assessment for dysplasia grade

Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia

STRATICYTE Assessment PROCEDURE

Assessment for risk of progression to oral cancer

Also known as: S100A7 Immunohistochemistry Signature-based Assessment

Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be selected from community-based Oral \& Maxillofacial Surgery practices in the provinces of Ontario and Alberta, Canada

You may qualify if:

• Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia/oral squamous cell carcinoma

You may not qualify if:

• Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy

Sponsors & Collaborators

• Proteocyte Diagnostics Inc.: lead

Study Sites (3)

Kingsway Oral & Maxillofacial Surgery

Edmonton, Alberta, T5M 3Z7, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

RECRUITING

Western University

London, Ontario, N6A 5C1, Canada

RECRUITING

Related Publications (6)

• Hwang JTK, Dammling C, McCord C, McGuire T, Park EP, Filkowski J, Shaw E, McMullen S, Nwigwe A, Ekwaru JP, McGaw WT, Lung KE, Seikaly H, Renick B, Lin DM, Morlandt A, Pritzker KH, Darling MR. External Validation of Straticyte, a Quantitative Biomarker-Based Risk Assay in Predicting Oral Cancer. J Maxillofac Oral Surg. 2025 Oct;24(5):1351-1357. doi: 10.1007/s12663-024-02362-7. Epub 2024 Oct 29.

  PMID: 41054469 BACKGROUND

• Hwang JT, Gu YR, Shen M, Ralhan R, Walfish PG, Pritzker KP, Mock D. Individualized five-year risk assessment for oral premalignant lesion progression to cancer. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Mar;123(3):374-381. doi: 10.1016/j.oooo.2016.11.004. Epub 2016 Nov 22.

  PMID: 28110942 BACKGROUND

• Kaur J, Matta A, Kak I, Srivastava G, Assi J, Leong I, Witterick I, Colgan TJ, Macmillan C, Siu KW, Walfish PG, Ralhan R. S100A7 overexpression is a predictive marker for high risk of malignant transformation in oral dysplasia. Int J Cancer. 2014 Mar 15;134(6):1379-88. doi: 10.1002/ijc.28473. Epub 2013 Oct 8.

  PMID: 24122701 BACKGROUND

• Tripathi SC, Matta A, Kaur J, Grigull J, Chauhan SS, Thakar A, Shukla NK, Duggal R, DattaGupta S, Ralhan R, Siu KW. Nuclear S100A7 is associated with poor prognosis in head and neck cancer. PLoS One. 2010 Aug 3;5(8):e11939. doi: 10.1371/journal.pone.0011939.

  PMID: 20689826 BACKGROUND

• Ralhan R, Desouza LV, Matta A, Tripathi SC, Ghanny S, Dattagupta S, Thakar A, Chauhan SS, Siu KW. iTRAQ-multidimensional liquid chromatography and tandem mass spectrometry-based identification of potential biomarkers of oral epithelial dysplasia and novel networks between inflammation and premalignancy. J Proteome Res. 2009 Jan;8(1):300-9. doi: 10.1021/pr800501j.

  PMID: 19072117 BACKGROUND

• Ralhan R, Desouza LV, Matta A, Tripathi SC, Ghanny S, Datta Gupta S, Bahadur S, Siu KW. Discovery and verification of head-and-neck cancer biomarkers by differential protein expression analysis using iTRAQ labeling, multidimensional liquid chromatography, and tandem mass spectrometry. Mol Cell Proteomics. 2008 Jun;7(6):1162-73. doi: 10.1074/mcp.M700500-MCP200. Epub 2008 Mar 13.

  PMID: 18339795 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin-fixed paraffin-embedded tissue sections stained with H\&E and S100A7

MeSH Terms

Conditions

Mouth Neoplasms; Leukoplakia; Erythroplasia; Disease; Hyperplasia; Keratoderma, Palmoplantar, Epidermolytic; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Precancerous Conditions; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Keratoderma, Palmoplantar, Diffuse; Keratoderma, Palmoplantar; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mark Darling, MSc, MChD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Hwang, PhD

CONTACT

(647) 255-1370; jhwang@proteocyte.com

Mark Darling, MSc, MChD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 10, 2020
• Study Start: March 12, 2015
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

CA (3)