Mouth Diseases
Conditions
Keywords
Leukoplakia, Erythroplakia, Erythroleukoplakia, Lesion, Oral epithelial dysplasia, S100A7 biomarker, S100A7 Immunohistochemistry Signature-based, Early Diagnosis, STRATICYTE, Oral neoplasia, Oral epithelial atypia, Hyperplasia, Hyperkeratosis, Potentially premalignant oral epithelial lesion, Oral potentially malignant disorders, Mild dysplasia, Moderate dysplasia, Severe dysplasia, Low-grade dyspalsia, High-grade dysplasia, Personalized medicine, Predictive Assay, Whole slide imaging, Computational pathology, Digital pathology, Oral potentially malignant lesion
Brief 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.
Detailed 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.
Interventions
OTHERSTRATICYTE™ Test
Assessment for risk of progression to oral cancer
Sponsors
The University of Texas Health Science Center, Houston
Loma Linda University
Minnesota Oral & Facial Surgery
University of Alabama at Birmingham
Proteocyte Diagnostics Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | 5 years | Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy |
| Survival analysis | 5 years | Kaplan-Meier analyses to compare time to a positive diagnosis of oral cancer between patients/biopsies with a STRATICYTE™ classification of Low- and Elevated-Risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC | 5 years | Area under the receiver operator curve |
| C-index (Harrell's) | 5 years | From all possible pairs of patients, compute the number of concordant and discordant pairs. Compute C-index as the proportion of all possible pairs that are concordant. |
Countries
United States
Contacts
Primary ContactJody Filkowski, BSc, MSc, PhD
Backup ContactJason TK Hwang, HBSc, MSc, PhD
Outcome results
None listed