RecruitingNCT05853783
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
Sponsor
Proteocyte Diagnostics Inc.
Enrollment
180 participants
Start Date
Jan 1, 2023
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria2
- 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.
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Interventions
OTHERSTRATICYTE™ Test
Assessment for risk of progression to oral cancer
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05853783