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Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
RecruitingObservational study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- STRATICYTE™ Test (other)
Sponsor: Proteocyte Diagnostics Inc. · Participants: 180 · Started: Jan 1, 2023
Contact the study team
- Jody Filkowski, BSc, MSc, PhD · Phone: 1-825-305-0749
- Jason TK Hwang, HBSc, MSc, PhD · Phone: 1-647-255-1370
Official record on ClinicalTrials.gov — NCT05853783
Locations in the U.S.
| Texas | MD Anderson Cancer Cetner, Houston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.