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

November 5, 2024 updated by: Proteocyte Diagnostics Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Completed
        • The University of Alabama at Birmingham
    • California
      • Loma Linda, California, United States, 92350
        • Completed
        • Loma Linda University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Withdrawn
        • Minnesota Oral and Facial Surgery
    • Texas
      • Houston, Texas, United States, 44907
        • Recruiting
        • MD Anderson Cancer Cetner
        • Contact:
          • Andrew G Sikora, MD, PhD
      • Houston, Texas, United States, 77054
        • Completed
        • UTHealth Houston School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population are patients presenting with an OPMD who have received a biopsy of their lesion. The study sample will be composed of patients with previously biopsied OPMDs from contracted clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OPMDs that progressed to OSCC
No dysplasia, mild, moderate, severe dysplasia, CIS
Other: STRATICYTE™ Test
Assessment for risk of progression to oral cancer
Other Names:
  • S100A7 Immunohistochemistry Signature-based Test
OPMDs that did not progress to OSCC
No dysplasia, mild, moderate, severe dysplasia, CIS
Other: STRATICYTE™ Test
Assessment for risk of progression to oral cancer
Other Names:
  • S100A7 Immunohistochemistry Signature-based Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: 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
5 years
Survival analysis
Time Frame: 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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 5 years
Area under the receiver operator curve
5 years
C-index (Harrell's)
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proteocyte Diagnostics Inc.

Collaborators

The University of Texas Health Science Center, Houston
University of Alabama at Birmingham
Loma Linda University
Minnesota Oral & Facial Surgery

Investigators

  • Principal Investigator: Simon W Young, DDS, MD, PhD, UTHealthHouston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-STR-PPOEL-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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