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

Proteocyte Diagnostics

Status: Enrolling

Conditions: Oral Neoplasm

Treatments: Procedure: Standard of Care Histopathology; Procedure: STRATICYTE Assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT04622462

PRO-STR-PPOEL-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 500 estimated patients

Sex: All

Ages: 15 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia

Description:

No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia

Treatment:

Procedure: STRATICYTE Assessment

Procedure: Standard of Care Histopathology