Actively Recruiting
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
Eligibility Criteria
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
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
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Withdrawn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
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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