Oral NeoplasmNCT04622462
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment
An observational study of Oral Neoplasm, run by Proteocyte Diagnostics Inc. at 3 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Oral Neoplasm
- What is being tested?
- STRATICYTE Assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 500 participants
- Where
- 3 sitesCanada
- Study dates
- 12 Mar 2015to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be selected from community-based Oral \& Maxillofacial Surgery practices in the provinces of Ontario and Alberta, Canada
Who may be able to join
- Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia/oral squamous cell carcinoma
Who cannot join
- Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Kingsway Oral & Maxillofacial Surgery
Edmonton, Alberta, T5M 3Z7
Tim McGaw, DDS, MSc, MD
Tim McGaw, DDS, MSc, MD
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 1C9
Tim McGaw, DDS, MSc, MD
Tim McGaw, DDS, MSc, MD
- Recruiting
Western University
London, Ontario, N6A 5C1
Mark Darling, MSc, MChD
Mark Darling, MSc, MChD
About this study
Official title: A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE
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.
Read the detailed description
Background: The standard of care for potentially premalignant oral epithelial lesion (PPOEL) risk assessment for progression to cancer is dysplasia grading by histopathology. With significant overlap between dysplasia grades and high inter- and intra-observer variations, dysplasia grading alone has been shown to be inadequate as a prognostic tool. To investigate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in the early diagnosis of invasive oral cancer, a prospective multi-center observational study was designed with specimens obtained from community-based practices.
Methods: Patients that qualify to enroll in the study will be assessed for both standard of care histopathological assessment for dysplasia grade and STRATICYTE risk assessment, and followed for up to 60 months (from initial biopsy) to determine the outcome of their oral lesion(s).
- Conditions
- Oral Neoplasm
- Being tested
- Standard of Care Histopathology, STRATICYTE Assessment
- Keywords
- Leukoplakia, Erythroplakia, Erythroleukoplakia, Lesion, Oral Epithelial Dysplasia, S100A7 Biomarker, S100A7 Immunohistochemistry Signature-based, Early Diagnosis, STRATICYTE, Oral Neoplasia, Oral Epithelial Atypia, Hyperplasia, Hyperkeratosis, Oral Squamous Cell Carcinoma, Oral Cancer, Potentially Premalignant Oral Epithelial Lesion, OPMD, Mild Dysplasia, Moderate Dysplasia, Severe Dysplasia
- Medical subject headings
- Mouth Neoplasms, Leukoplakia, Erythroplasia, Disease, Hyperplasia, Keratoderma, Palmoplantar, Epidermolytic, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care HistopathologyProcedure or surgery
Also called H&E assessment for dysplasia grade
Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer
STRATICYTE AssessmentProcedure or surgery
Also called S100A7 Immunohistochemistry Signature-based Assessment
Assessment for risk of progression to oral cancer
| Study group | Role | What they receive |
|---|---|---|
| Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia | No evidence of dysplasia
Mild dysplasia
Moderate dysplasia
Severe dysplasia Receives: Procedure: Standard of Care Histopathology; Procedure: STRATICYTE Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant Transformation Rate: Dysplasia
Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk
Measured: 60 months
Secondary outcomes (2)
Malignant Transformation Rate: No Dysplasia
Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk
Measured: 60 months
Recurrence Rate
Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start12 Mar 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Oral NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proteocyte Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Darling, MSc, MChD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622462
- Sponsor's protocol ID
- PRO-STR-PPOEL-1
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2020
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28110942Kaur 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.
PubMed 24122701Tripathi 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.
PubMed 20689826Ralhan 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.
PubMed 19072117Ralhan 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.
PubMed 18339795Hwang 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.
PubMed 41054469