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

Titre officiel

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

Sommaire:

Le but de cette étude observationnelle est d’évaluer l’utilité de l’épreuve diagnostique appelée STRATICYTE évaluant la signature immunohistochimique de la protéine S100-A7 afin de déterminer le risque de progression cancéreuse de lésions buccales cliniquement suspectes.

Description de l'essai

Primary Outcome:

• Malignant Transformation Rate: Dysplasia

Secondary Outcome:

• Malignant Transformation Rate: No Dysplasia
• Recurrence Rate

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-centre 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).

Voir cet essai sur ClinicalTrials.gov