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

  • End date
    Dec 31, 2026
  • participants needed
  • sponsor
    Proteocyte Diagnostics Inc.
Updated on 27 January 2021


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.


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).

Condition Oral Neoplasm, Oral Cavity Cancer, Oral Cancer, head and neck cancer, head and neck cancer, Oral Cavity Cancer, Oral Cancer
Treatment Standard of Care Histopathology, STRATICYTE Assessment
Clinical Study IdentifierNCT04622462
SponsorProteocyte Diagnostics Inc.
Last Modified on27 January 2021


Yes No Not Sure

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
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