Clinical trial · Observational
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment
A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE
NCT04622462CI-TRIAL-00082308recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Neoplasm | Oral Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care Histopathology | Procedure | — | UNRESOLVED |
| STRATICYTE Assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia
- description
- No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia
- interventionNames
- Procedure: Standard of Care Histopathology
- Procedure: STRATICYTE Assessment
Primary outcomes (1)
- measure
- Malignant Transformation Rate: Dysplasia
- timeFrame
- 60 months
- description
- Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk
Secondary outcomes (2)
- measure
- Malignant Transformation Rate: No Dysplasia
- timeFrame
- 60 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDHwang 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. PMID 28110942
- BACKGROUNDKaur 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. PMID 24122701
- BACKGROUNDTripathi 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. PMID 20689826
- BACKGROUNDRalhan 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. PMID 19072117
- BACKGROUNDRalhan 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. PMID 18339795
- RESULTHwang 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.