Study of STRATICYTE Test to Predict Oral Potentially Malignant Disorders Progressing to Oral Cancer

What this Trial Is About

Researchers are evaluating the STRATICYTE12 predictive model to see how well it can predict the transformation of oral potentially malignant disorders OPMDs into oral squamous cell carcinoma OSCC. This study focuses on a retrospective group of patients who had biopsies taken for oral lesions. The main goals include assessing the models sensitivity and specificity, understanding which patient and clinical factors affect its accuracy, and estimating how STRATICYTE12 results relate to the time until a positive oral cancer diagnosis. The study involves analyzing biopsy tissue samples from patients with various grades of oral epithelial dysplasia, including no dysplasia, mild, moderate, severe dysplasia, and carcinoma in situ CIS. Participants are grouped based on whether their OPMDs progressed to OSCC or not. STRATICYTE12 testing is used to assess the risk of progression to oral cancer by reviewing archived biopsy tissue blocks from clinical centers. Participants archived biopsy data and clinical follow-up records over at least five years are reviewed. Researchers measure the STRATICYTE12 tests sensitivity, specificity, area under the curve AUC, and Harrells C-index, along with survival analysis over five years. The study tracks the correlation of STRATICYTE12 outcomes with oral cancer development timing. No new treatments or procedures are performed during this observational study, and the overall participation involves data analysis from past biopsies and clinical records.

Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™