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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 10, 2020
Sponsor:
Information provided by (Responsible Party):
Proteocyte Diagnostics Inc.

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).

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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, 2021
Estimated Study Completion Date : December 31, 2026


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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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


Information from the National Library of Medicine

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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

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
Publications:

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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 10, 2020
Last Verified: November 2020
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