Actively Recruiting

Age: 18Years +
All Genders
ID05853783

Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE12

Led by Proteocyte Diagnostics Inc. · Updated on 2024-11-07

180

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

P

Proteocyte Diagnostics Inc.

Lead Sponsor

T

The University of Texas Health Science Center, Houston

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the STRATICYTE12 predictive model to see how well it can predict the transformation of oral potentially malignant disorders (OPMDs) into oral squamous cell carcinoma (OSCC). This study focuses on a retrospective group of patients who had biopsies taken for oral lesions. The main goals include assessing the model's sensitivity and specificity, understanding which patient and clinical factors affect its accuracy, and estimating how STRATICYTE12 results relate to the time until a positive oral cancer diagnosis. The study involves analyzing biopsy tissue samples from patients with various grades of oral epithelial dysplasia, including no dysplasia, mild, moderate, severe dysplasia, and carcinoma in situ (CIS). Participants are grouped based on whether their OPMDs progressed to OSCC or not. STRATICYTE12 testing is used to assess the risk of progression to oral cancer by reviewing archived biopsy tissue blocks from clinical centers. Participants' archived biopsy data and clinical follow-up records over at least five years are reviewed. Researchers measure the STRATICYTE12 test's sensitivity, specificity, area under the curve (AUC), and Harrell's C-index, along with survival analysis over five years. The study tracks the correlation of STRATICYTE12 outcomes with oral cancer development timing. No new treatments or procedures are performed during this observational study, and the overall participation involves data analysis from past biopsies and clinical records.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • From the archive, any patient with clinically evident oral lesions and biopsy-proven dysplasia (any grade or classification system)
  • Patients with initial oral lesions suspicious for neoplasia but no cancer, with clinical follow-up of at least five years
  • Patients who developed oral squamous cell carcinoma (OSCC) with documented evidence
  • Patients with archived biopsy tissue blocks of previous oral lesions retained at the same clinical center
Not Eligible

You will not qualify if you...

  • Patients with oral lesions or dysplasia without evidence of OSCC development and follow-up data less than five years
  • Patients diagnosed with oral epithelial dysplasia alongside OSCC at the time of biopsy or with cancer progression within three months after biopsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Initial assessment with retrospective data review over 5 years

Participants undergo the STRATICYTE™ test to assess the risk of progression to oral cancer.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are observed over a period of 5 years to monitor clinical outcomes and progression to oral squamous cell carcinoma.

Follow-up assessments depending on clinical records and routine care

Trial Site Locations

Total: 5 locations

1

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Completed

2

Loma Linda University

Loma Linda, California, United States, 92350

Completed

3

Minnesota Oral and Facial Surgery

Minneapolis, Minnesota, United States, 55415

Withdrawn

4

MD Anderson Cancer Cetner

Houston, Texas, United States, 44907

Actively Recruiting

5

UTHealth Houston School of Dentistry

Houston, Texas, United States, 77054

Completed

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Research Team

J

Jody Filkowski, BSc, MSc, PhD

J

Jason TK Hwang, HBSc, MSc, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

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Ranju Ralhan, Leroi V Desouza, Ajay Matta...

https://pubmed.ncbi.nlm.nih.gov/18339795

iTRAQ-multidimensional liquid chromatography and tandem mass spectrometry-based identification of potential biomarkers of oral epithelial dysplasia and novel networks between inflammation and premalignancy.

Ranju Ralhan, Leroi V Desouza, Ajay Matta...

https://pubmed.ncbi.nlm.nih.gov/19072117