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

Recruitingn/aAges 18 Years - anyAllProteocyte Diagnostics Inc.
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • STRATICYTE™ Test
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Where

5 sites
The University of Alabama at Birmingham
Birmingham, United States
Loma Linda University
Loma Linda, United States
Minnesota Oral and Facial Surgery
Minneapolis, United States
MD Anderson Cancer Cetner
Houston, United States
UTHealth Houston School of Dentistry
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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