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

Oral Neoplasm Clinical Trial

Official title:

A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622462
• Other study ID #: PRO-STR-PPOEL-1
• Status: Recruiting
• Start date: March 12, 2015
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Proteocyte Diagnostics Inc.
• Contact: Jason Hwang, PhD
• Phone: (647) 255-1370
• Email: jhwang[@]proteocyte.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Neoplasm

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Canada	Kingsway Oral & Maxillofacial Surgery	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Proteocyte Diagnostics Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malignant Transformation Rate: Dysplasia	Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk	60 months
Secondary	Malignant Transformation Rate: No Dysplasia	Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk	60 months
Secondary	Recurrence Rate	Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk	60 months