Evaluating a predictive model for oral cancer risk in patients with mouth lesions
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
This study is testing a new tool to see if it can predict which patients with mouth lesions are at risk of developing oral cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Proteocyte Diagnostics Inc. Industry-sponsored |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT05853783 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the STRATICYTE™ predictive model's ability to forecast the transformation of oral potentially malignant disorders (OPMDs) into oral squamous cell carcinoma (OSCC). It will assess the model's sensitivity and specificity in a cohort of patients with biopsy-proven dysplasia and identify clinical characteristics that may influence these metrics. Additionally, the study will estimate the correlation between STRATICYTE™ outcomes and the time to a positive diagnosis of oral cancer, utilizing archived biopsy data from participating institutions.
Who should consider this trial
Good fit: Ideal candidates include patients with clinically evident oral lesions and biopsy-proven dysplasia who have follow-up data for at least five years.
Not a fit: Patients with oral lesions that do not show signs of OSCC development or lack sufficient follow-up data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting the risk of oral cancer in patients with potentially malignant lesions, leading to earlier interventions.
How similar studies have performed: Other studies have explored predictive models for oral cancer, but the specific application of STRATICYTE™ in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 4 other locations
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (Completed)
- Loma Linda University — Loma Linda, California, United States (Completed)
- Minnesota Oral and Facial Surgery — Minneapolis, Minnesota, United States (Withdrawn)
- MD Anderson Cancer Cetner — Houston, Texas, United States (Recruiting)
- UTHealth Houston School of Dentistry — Houston, Texas, United States (Completed)
Study contacts
- Principal investigator: Simon W Young, DDS, MD, PhD — UTHealthHouston
- Study coordinator: Jody Filkowski, BSc, MSc, PhD
- Email: Jody.Filkowski@medlior.com
- Phone: 1-825-305-0749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.