Assessing the risk of oral cancer using S100A7 immunohistochemistry
A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE
This study is testing a new method called STRATICYTE to see if it can better predict the risk of oral cancer in patients with suspicious mouth lesions compared to standard tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 15 Years to 90 Years |
| Sex | All |
| Sponsor | Proteocyte Diagnostics Inc. Industry-sponsored |
| Locations | 3 sites (Edmonton, Alberta and 2 other locations) |
| Trial ID | NCT04622462 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the S100A7 immunohistochemistry signature-based assessment, known as STRATICYTE, in predicting the risk of progression to cancer in clinically suspicious oral lesions. The study aims to improve upon traditional dysplasia grading by providing a more reliable prognostic tool for potentially premalignant oral epithelial lesions. Patients will undergo both standard histopathological assessments and STRATICYTE evaluations, with follow-up lasting up to 60 months to monitor outcomes related to their oral lesions.
Who should consider this trial
Good fit: Ideal candidates include individuals with clinically suspicious oral lesions that require biopsy to rule out dysplasia or oral squamous cell carcinoma.
Not a fit: Patients with biopsied lesions already diagnosed with oral squamous cell carcinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate identification of patients at risk for oral cancer, allowing for timely intervention.
How similar studies have performed: While the approach of using immunohistochemistry for cancer risk assessment is established, the specific application of the S100A7 signature in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia/oral squamous cell carcinoma Exclusion Criteria: * Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy
Where this trial is running
Edmonton, Alberta and 2 other locations
- Kingsway Oral & Maxillofacial Surgery — Edmonton, Alberta, Canada (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- Western University — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mark Darling, MSc, MChD — Western University
- Study coordinator: Jason Hwang, PhD
- Email: jhwang@proteocyte.com
- Phone: (647) 255-1370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.