Overview
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:
- Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria.
- Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model.
- Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.
Eligibility
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.