RecruitingObservational

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

NCT ID: NCT05853783Sponsor: Proteocyte Diagnostics Inc.Last updated: 2024-11-07

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.

Arms & interventions

OtherSTRATICYTE™ Test
Assessment for risk of progression to oral cancer

Outcome measures

Primary

Sensitivity 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

Secondary

AUC
Time frame: 5 years
C-index (Harrell's)
Time frame: 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (5)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233

Completed

Loma Linda University

Loma Linda, California, 92350

Completed

Minnesota Oral and Facial Surgery

Minneapolis, Minnesota, 55415

Withdrawn

MD Anderson Cancer Cetner

Houston, Texas, 44907

Recruiting

Andrew G Sikora, MD, PhD · Contact

UTHealth Houston School of Dentistry

Houston, Texas, 77054

Completed

References

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