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

Recruiting now

Conditions studied: Mouth Diseases

In brief

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.

Key facts

Study ID

NCT05853783

Run by

Proteocyte Diagnostics Inc.

People needed

180

Starts

2023-01-01

Expected to finish

2024-12-01

Last updated by the study team

2024-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MD Anderson Cancer Cetner — Houston, Texas, United States (enrolling)
• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Loma Linda University — Loma Linda, California, United States
• Minnesota Oral and Facial Surgery — Minneapolis, Minnesota, United States
• UTHealth Houston School of Dentistry — Houston, Texas, United States

Full record on ClinicalTrials.gov

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