Actively Recruiting

Age: 18Years +
All Genders
NCT05853783

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

Led by Proteocyte Diagnostics Inc. · Updated on 2024-11-07

180

Participants Needed

5

Research Sites

100 weeks

Total Duration

On this page

Sponsors

P

Proteocyte Diagnostics Inc.

Lead Sponsor

T

The University of Texas Health Science Center, Houston

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with clinically evident oral lesions and biopsy-proven dysplasia (any grade or classification system) from punch or scalpel biopsies
  • Patients with oral lesions suspicious for cancer but no histological evidence of cancer, with at least five years of clinical follow-up data
  • Patients who developed oral squamous cell carcinoma confirmed by histology or documented invasive cancer
  • Patients with archived biopsy tissue blocks of previous oral lesions maintained at the same clinical center
Not Eligible

You will not qualify if you...

  • Patients with oral lesions or dysplasia without any indication of oral squamous cell carcinoma development and less than five years of follow-up data
  • Patients diagnosed with oral epithelial dysplasia together with oral squamous cell carcinoma at the time of the biopsy or within three months after the biopsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Completed

2

Loma Linda University

Loma Linda, California, United States, 92350

Completed

3

Minnesota Oral and Facial Surgery

Minneapolis, Minnesota, United States, 55415

Withdrawn

4

MD Anderson Cancer Cetner

Houston, Texas, United States, 44907

Actively Recruiting

5

UTHealth Houston School of Dentistry

Houston, Texas, United States, 77054

Completed

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Research Team

J

Jody Filkowski, BSc, MSc, PhD

CONTACT

J

Jason TK Hwang, HBSc, MSc, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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