Clinical trial NCT04622462: Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment
Official title: A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions with STRATICYTE
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Proteocyte Diagnostics Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-10
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility 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

Primary outcomes:
measure: Malignant Transformation Rate: Dysplasia
timeFrame: 60 months
Secondary outcomes:
measure: Malignant Transformation Rate: No Dysplasia
timeFrame: 60 months
measure: Recurrence Rate
timeFrame: 60 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Kingsway Oral & Maxillofacial Surgery
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University
name: Mark Darling, MSc, MChD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hwang, J.T.K., Dammling, C., McCord, C. et al. External Validation of Straticyte™, a Quantitative Biomarker-Based Risk Assay in Predicting Oral Cancer. J. Maxillofac. Oral Surg. (2024). https://doi.org/10.1007/s12663-024-02362-7
citation: 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.
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.
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.
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.
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.