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

Mouth Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853783
• Other study ID #: PRO-STR-PPOEL-2
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Proteocyte Diagnostics Inc.
• Contact: Jody Filkowski, BSc, MSc, PhD
• Phone: 1-825-305-0749
• Email: Jody.Filkowski[@]medlior.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mouth Diseases

Intervention

Other:
• STRATICYTE™ Test
Assessment for risk of progression to oral cancer

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	MD Anderson Cancer Cetner	Houston	Texas
United States	UTHealth Houston School of Dentistry	Houston	Texas
United States	Loma Linda University	Loma Linda	California
United States	Minnesota Oral and Facial Surgery	Minneapolis	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
Proteocyte Diagnostics Inc.	Loma Linda University, Minnesota Oral & Facial Surgery, The University of Texas Health Science Center, Houston, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	5 years
Primary	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	AUC	Area under the receiver operator curve	5 years
Secondary	C-index (Harrell's)	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

External Links

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