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NCT Number: NCT04622462

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

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.

Recruiting

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Key information

Conditions

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

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingsway Oral & Maxillofacial Surgery, Edmonton, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care Histopathology

Procedure

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

Other names: H&E assessment for dysplasia grade

STRATICYTE Assessment

Procedure

Assessment for risk of progression to oral cancer

Other names: S100A7 Immunohistochemistry Signature-based Assessment

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Hwang, PhD

CONTACT

[email protected]

(647) 255-1370

Mark Darling, MSc, MChD

CONTACT

[email protected]

(519) 661-2111 ext. 86399

Sponsors and collaborators

Lead sponsor

Proteocyte Diagnostics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Nov 10, 2020
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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