Testing a Method to Predict Cancer Risk in Suspicious Mouth Sores
Tests a STRATICYTE test to judge if suspicious mouth lesions may become cancer.
Key facts
- Who runs it
- Proteocyte Diagnostics Inc.
- Where
- Edmonton and London, CanadaSee the 3 sites
- Trial code
- Registry title
- Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 12 Mar 2015
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Treatments tested
- Standard of Care Histopathology
- STRATICYTE Assessment
- Record updated
- 7 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with a suspicious spot in the mouth that was sampled (biopsy) to check for early changes or mouth cancer.
- Age
- 15 Years to 90 Years
- Sex
- All sexes can join.
- Disease stage
- A clinically suspicious lesion in the mouth that was biopsied to rule out oral epithelial dysplasia or oral squamous cell carcinoma.
Main reasons for not taking part
- A biopsied lesion, with or without dysplasia, that already shows oral squamous cell carcinoma at the first biopsy
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia/oral squamous cell carcinoma
Who cannot take part
- Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 90 years old?
Where in Canada
- Kingsway Oral & Maxillofacial SurgeryEdmonton, CanadaContact: Tim McGaw, DDS, MSc, MDTaking people
- University of AlbertaEdmonton, CanadaContact: Tim McGaw, DDS, MSc, MDTaking people
- Western UniversityLondon, CanadaContact: Mark Darling, MSc, MChDTaking people
About the trial
What the trial wants to find out
The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral lesions.
The group in the trial
- Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia
No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia
Treatment: Standard of Care Histopathology and STRATICYTE Assessment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE
- Plain-language title
- Testing a Method to Predict Cancer Risk in Suspicious Mouth SoresGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04622462, who can take part
- Record updated
- 7 November 2024