Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Neoplasms

Rare Diseases

Keratosis

Hyperplasia

Mouth Diseases

Precancerous Conditions

Leukoplakia

Erythroplasia

Stomatognathic Diseases

Erythroplakia

No dysplasia, mild, moderate, severe dysplasia, CIS

Assessment for risk of progression to oral cancer

STRATICYTE™ Test

Jody Filkowski, BSc, MSc, PhD

Jason TK Hwang, HBSc, MSc, PhD

Andrew G Sikora, MD, PhD

Simon W Young, DDS, MD, PhD

The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.

The study objectives are to:

1. Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria.
2. Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model.
3. Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.

FFPE specimens immunohistochemically stained with S100A7

Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™

Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy

Kaplan-Meier analyses to compare time to a positive diagnosis of oral cancer between patients/biopsies with a STRATICYTE™ classification of Low- and Elevated-Risk.

From all possible pairs of patients, compute the number of concordant and discordant pairs. Compute C-index as the proportion of all possible pairs that are concordant.

The University of Texas Health Science Center, Houston

Loma Linda University

Minnesota Oral & Facial Surgery

University of Alabama at Birmingham

Proteocyte Diagnostics Inc.

Carcinoma

Carcinoma, Squamous Cell

Disease Progression

Mouth Neoplasms

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

No evidence of dysplasia

Mild dysplasia

Moderate dysplasia

Severe dysplasia

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

Standard of Care Histopathology

STRATICYTE Assessment

Jason Hwang, PhD

Mark Darling, MSc, MChD

Tim McGaw, DDS, MSc, MD

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).

Formalin-fixed paraffin-embedded tissue sections stained with H\&E and S100A7

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

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

Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk

Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™	NCT05853783	Mouth Diseases	STRATICYTE™ Tes...	18 Years -	Proteocyte Diagnostics Inc.
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment	NCT04622462	Oral Neoplasm	Standard of Car... STRATICYTE Asse...	15 Years - 90 Years	Proteocyte Diagnostics Inc.

Spots Global Cancer Trial Database for severe dysplasia