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

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ClinicalTrials.gov Identifier: NCT04622462

Recruitment Status : Recruiting

First Posted : November 10, 2020

Last Update Posted : November 14, 2022

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Proteocyte Diagnostics Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Oral Neoplasm	Procedure: Standard of Care Histopathology Procedure: STRATICYTE Assessment

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 Design

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE
Actual Study Start Date :	March 12, 2015
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup Oral Cancer

Genetic and Rare Diseases Information Center resources: Oral Cancer Oral Squamous Cell Carcinoma Lip and Oral Cavity Cancer Leukoplakia Erythroplakia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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 Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer Other Name: H&E assessment for dysplasia grade Procedure: STRATICYTE Assessment Assessment for risk of progression to oral cancer Other Name: S100A7 Immunohistochemistry Signature-based Assessment

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Biospecimen Retention: Samples Without DNA

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

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 90 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622462

Contacts

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Contact: Jason Hwang, PhD	(647) 255-1370	jhwang@proteocyte.com
Contact: Mark Darling, MSc, MChD	(519) 661-2111 ext 86399	mark.darling@schulich.uwo.ca

Locations

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Canada, Alberta
Kingsway Oral & Maxillofacial Surgery	Recruiting
Edmonton, Alberta, Canada, T5M 3Z7
Contact: Tim McGaw, DDS, MSc, MD
Principal Investigator: Tim McGaw, DDS, MSc, MD
University of Alberta	Recruiting
Edmonton, Alberta, Canada, T6G 1C9
Contact: Tim McGaw, DDS, MSc, MD
Principal Investigator: Tim McGaw, DDS, MSc, MD
Canada, Ontario
Western University	Recruiting
London, Ontario, Canada, N6A 5C1
Contact: Mark Darling, MSc, MChD
Principal Investigator: Mark Darling, MSc, MChD

Sponsors and Collaborators

Proteocyte Diagnostics Inc.

Investigators

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Principal Investigator:	Mark Darling, MSc, MChD	Western University

More Information

Publications:

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.

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.

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.

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.

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.

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Responsible Party:	Proteocyte Diagnostics Inc.
ClinicalTrials.gov Identifier:	NCT04622462
Other Study ID Numbers:	PRO-STR-PPOEL-1
First Posted:	November 10, 2020 Key Record Dates
Last Update Posted:	November 14, 2022
Last Verified:	November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Proteocyte Diagnostics Inc.:


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

Additional relevant MeSH terms:

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Mouth Neoplasms Head and Neck Neoplasms Neoplasms by Site	Neoplasms Mouth Diseases Stomatognathic Diseases

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