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

Purpose

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.

Condition

  • Mouth Diseases

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

MD Anderson Cancer Cetner
Houston, Texas 44907
Contact:
Andrew G Sikora, MD, PhD

More Details

Status
Recruiting
Sponsor
Proteocyte Diagnostics Inc.

Study Contact

Jody Filkowski, BSc, MSc, PhD
1-825-305-0749
Jody.Filkowski@medlior.com

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.