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NCT05853783Recruiting

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

Proteocyte Diagnostics Inc.

Start Date

1/1/2023

Completion Date

12/1/2024

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * From the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system) * Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with: * No histological evidence of cancer with clinical follow-up data for a period of at least five years; or * OSCC development (histologic or documented evidence of invasive cancer). * Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center. Exclusion Criteria: * Patients with oral lesions or dysplasia with no indication of OSCC development or follow-up data of less than five years in non-OSCC patients. * Patients diagnosed with oral epithelial dysplasia concomitant with OSCC at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.

Interventions

OTHER

STRATICYTE™ Test

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Conditions

Mouth Diseases

Locations

The University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Loma Linda University

Loma Linda, California 92350

United States

Minnesota Oral and Facial Surgery

Minneapolis, Minnesota 55415

United States

MD Anderson Cancer Cetner

Houston, Texas 44907

United States

UTHealth Houston School of Dentistry

Houston, Texas 77054

United States