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

NCT05853783 | Recruiting DMC

• 1 other identifier: PRO-STR-PPOEL-2
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 5

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.

Conditions

Mouth Diseases

Keywords

Leukoplakia; Erythroplakia; Erythroleukoplakia; Lesion; Oral epithelial dysplasia; S100A7 biomarker; S100A7 Immunohistochemistry Signature-based; Early Diagnosis; STRATICYTE; Oral neoplasia; Oral epithelial atypia; Hyperplasia; Hyperkeratosis; Potentially premalignant oral epithelial lesion; Oral potentially malignant disorders; Mild dysplasia; Moderate dysplasia; Severe dysplasia; Low-grade dyspalsia; High-grade dysplasia; Personalized medicine; Predictive Assay; Whole slide imaging; Computational pathology; Digital pathology; Oral potentially malignant lesion

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  5 years

Secondary Outcomes (2)

• AUC

  5 years

• C-index (Harrell's)

  5 years

Study Arms (2)

OPMDs that progressed to OSCC

No dysplasia, mild, moderate, severe dysplasia, CIS

Other: STRATICYTE™ Test

OPMDs that did not progress to OSCC

No dysplasia, mild, moderate, severe dysplasia, CIS

Other: STRATICYTE™ Test

Interventions

STRATICYTE™ Test OTHER

Assessment for risk of progression to oral cancer

Also known as: S100A7 Immunohistochemistry Signature-based Test

OPMDs that did not progress to OSCC; OPMDs that progressed to OSCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Proteocyte Diagnostics Inc.: lead
• The University of Texas Health Science Center, Houston: collaborator
• Loma Linda University: collaborator
• Minnesota Oral & Facial Surgery: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (5)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

COMPLETED

Loma Linda University

Loma Linda, California, 92350, United States

COMPLETED

Minnesota Oral and Facial Surgery

Minneapolis, Minnesota, 55415, United States

WITHDRAWN

MD Anderson Cancer Cetner

Houston, Texas, 44907, United States

RECRUITING

UTHealth Houston School of Dentistry

Houston, Texas, 77054, United States

COMPLETED

Related Publications (6)

• Hwang JTK, Dammling C, McCord C, McGuire T, Park EP, Filkowski J, Shaw E, McMullen S, Nwigwe A, Ekwaru JP, McGaw WT, Lung KE, Seikaly H, Renick B, Lin DM, Morlandt A, Pritzker KH, Darling MR. External Validation of Straticyte, a Quantitative Biomarker-Based Risk Assay in Predicting Oral Cancer. J Maxillofac Oral Surg. 2025 Oct;24(5):1351-1357. doi: 10.1007/s12663-024-02362-7. Epub 2024 Oct 29.

  PMID: 41054469 BACKGROUND

• Ralhan R, Desouza LV, Matta A, Tripathi SC, Ghanny S, Datta Gupta S, Bahadur S, Siu KW. Discovery and verification of head-and-neck cancer biomarkers by differential protein expression analysis using iTRAQ labeling, multidimensional liquid chromatography, and tandem mass spectrometry. Mol Cell Proteomics. 2008 Jun;7(6):1162-73. doi: 10.1074/mcp.M700500-MCP200. Epub 2008 Mar 13.

  PMID: 18339795 BACKGROUND

• Ralhan R, Desouza LV, Matta A, Tripathi SC, Ghanny S, Dattagupta S, Thakar A, Chauhan SS, Siu KW. iTRAQ-multidimensional liquid chromatography and tandem mass spectrometry-based identification of potential biomarkers of oral epithelial dysplasia and novel networks between inflammation and premalignancy. J Proteome Res. 2009 Jan;8(1):300-9. doi: 10.1021/pr800501j.

  PMID: 19072117 BACKGROUND

• Tripathi SC, Matta A, Kaur J, Grigull J, Chauhan SS, Thakar A, Shukla NK, Duggal R, DattaGupta S, Ralhan R, Siu KW. Nuclear S100A7 is associated with poor prognosis in head and neck cancer. PLoS One. 2010 Aug 3;5(8):e11939. doi: 10.1371/journal.pone.0011939.

  PMID: 20689826 BACKGROUND

• Kaur J, Matta A, Kak I, Srivastava G, Assi J, Leong I, Witterick I, Colgan TJ, Macmillan C, Siu KW, Walfish PG, Ralhan R. S100A7 overexpression is a predictive marker for high risk of malignant transformation in oral dysplasia. Int J Cancer. 2014 Mar 15;134(6):1379-88. doi: 10.1002/ijc.28473. Epub 2013 Oct 8.

  PMID: 24122701 BACKGROUND

• Hwang JT, Gu YR, Shen M, Ralhan R, Walfish PG, Pritzker KP, Mock D. Individualized five-year risk assessment for oral premalignant lesion progression to cancer. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Mar;123(3):374-381. doi: 10.1016/j.oooo.2016.11.004. Epub 2016 Nov 22.

  PMID: 28110942 BACKGROUND

Related Links

• Medlior Health Outcomes Research
• Oral Cancer Foundation
• Proteocyte Diagnostics Inc.

Biospecimen

Retention: SAMPLES WITHOUT DNA

FFPE specimens immunohistochemically stained with S100A7

MeSH Terms

Conditions

Mouth Diseases; Leukoplakia; Erythroplasia; Disease; Hyperplasia; Keratoderma, Palmoplantar, Epidermolytic

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Precancerous Conditions; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Keratoderma, Palmoplantar, Diffuse; Keratoderma, Palmoplantar; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Simon W Young, DDS, MD, PhD

  UTHealthHouston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jody Filkowski, BSc, MSc, PhD

CONTACT

1-825-305-0749; Jody.Filkowski@medlior.com

Jason TK Hwang, HBSc, MSc, PhD

CONTACT

1-647-255-1370; jhwang@proteocyte.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)