Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
Proteocyte Diagnostics Inc.
Summary
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.
Description
The study objectives are to: 1. Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria. 2. Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model. 3. Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 cl…
Interventions
- OtherSTRATICYTE™ Test
Assessment for risk of progression to oral cancer
Locations (5)
- The University of Alabama at BirminghamBirmingham, Alabama
- Loma Linda UniversityLoma Linda, California
- Minnesota Oral and Facial SurgeryMinneapolis, Minnesota
- MD Anderson Cancer CetnerHouston, Texas
- UTHealth Houston School of DentistryHouston, Texas