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.
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.
Study Type
OBSERVATIONAL
Enrollment
180
Assessment for risk of progression to oral cancer
The University of Alabama at Birmingham
Birmingham, Alabama, United States
COMPLETEDLoma Linda University
Loma Linda, California, United States
COMPLETEDMinnesota Oral and Facial Surgery
Minneapolis, Minnesota, United States
WITHDRAWNSensitivity and Specificity
Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy
Time frame: 5 years
Survival analysis
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.
Time frame: 5 years
AUC
Area under the receiver operator curve
Time frame: 5 years
C-index (Harrell's)
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.
Time frame: 5 years
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MD Anderson Cancer Cetner
Houston, Texas, United States
RECRUITINGUTHealth Houston School of Dentistry
Houston, Texas, United States
COMPLETED