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

Recruiting

• Conditions: Mouth Diseases
• Interventions: Other: STRATICYTE™ Test

• Registration Number: NCT05853783
• Lead Sponsor: Proteocyte Diagnostics Inc.

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OPMDs that progressed to OSCC	STRATICYTE™ Test	No dysplasia, mild, moderate, severe dysplasia, CIS
OPMDs that did not progress to OSCC	STRATICYTE™ Test	No dysplasia, mild, moderate, severe dysplasia, CIS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Minnesota Oral and Facial Surgery; 🇺🇸 Minneapolis, Minnesota, United States

MD Anderson Cancer Cetner; 🇺🇸 Houston, Texas, United States

UTHealth Houston School of Dentistry; 🇺🇸 Houston, Texas, United States