Clinical trial · Observational
Differential Mobility Spectrometry (DMS) Based Oral Tumor Analysis
NCT05902455CI-TRIAL-00068763unknownClinicalTrials.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 trial is a single-center, non-randomized feasibility study aiming to evaluate the feasibility of ex-vivo tissue analysis using differential mobility spectrometry (DMS) of tissue smoke generated by the use of an electrosurgical instrument. Patients recruited in the trial receive standard-of-care oral squamous cell carcinoma tumor excision surgery.
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 Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Punch biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with oral squamous cell carcinoma
- interventionNames
- Procedure: Punch biopsy
Primary outcomes (1)
- measure
- Sensitivity and specificity of normal and cancerous tissue identification by differential mobility spectrometry
- timeFrame
- Through study completion, an average of 1 year
- description
- The ATAS device records a molecular spectrum of the surgical smoke generated when the collected tissue samples are processed with an electrosurgical instrument in the research laboratory. The primary outcome of the study is to test the ability of the device to correctly distinguish cancerous tissue from normal tissue based on predicted differences in the spectrum.
Secondary outcomes (1)
- measure
- The influence of oral squamous cell carcinoma tumor thickness and infiltration depth on the resolution
- timeFrame
- Through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy diagnosed oral squamous cell carcinoma. * Tumor diameter of 2 cm or larger. * Operable patient that is willing to participate in the trial. Exclusion Criteria: * Tumor diameter less than 2 cm. * Patient that is unwilling to take part in the trial. * Patient that is not able to understand given information concerning the trial or to give concent to take part in the trial.
References
Publications (8)
- BACKGROUNDP Economopoulou, A Psyrri. Epidemiology, risk factors and pathogenesis of squamous cell tumours. 2017 European Society for Medical Oncology (ESMO) Essentials for Clinicians and Neck Cancers Chapter 1
- BACKGROUNDSuusyöpä, Käypä Hoito -suositus 2019 (2019 Finnish Clinical Practice Guideline for Oral Carcinoma)
- BACKGROUNDMcMahon J, O'Brien CJ, Pathak I, Hamill R, McNeil E, Hammersley N, Gardiner S, Junor E. Influence of condition of surgical margins on local recurrence and disease-specific survival in oral and oropharyngeal cancer. Br J Oral Maxillofac Surg. 2003 Aug;41(4):224-31. doi: 10.1016/s0266-4356(03)00119-0. PMID 12946663
- BACKGROUNDAnderson CR, Sisson K, Moncrieff M. A meta-analysis of margin size and local recurrence in oral squamous cell carcinoma. Oral Oncol. 2015 May;51(5):464-9. doi: 10.1016/j.oraloncology.2015.01.015. Epub 2015 Feb 21. PMID 25716108
- BACKGROUNDSutton DN, Brown JS, Rogers SN, Vaughan ED, Woolgar JA. The prognostic implications of the surgical margin in oral squamous cell carcinoma. Int J Oral Maxillofac Surg. 2003 Feb;32(1):30-4. doi: 10.1054/ijom.2002.0313. PMID 12653229
- BACKGROUNDLubek JE, Magliocca KR. Evaluation of the Bone Margin in Oral Squamous Cell Carcinoma. Oral Maxillofac Surg Clin North Am. 2017 Aug;29(3):281-292. doi: 10.1016/j.coms.2017.03.005. Epub 2017 May 24. PMID 28551338
- BACKGROUNDCovington JA, van der Schee MP, Edge AS, Boyle B, Savage RS, Arasaradnam RP. The application of FAIMS gas analysis in medical diagnostics. Analyst. 2015 Oct 21;140(20):6775-81. doi: 10.1039/c5an00868a. PMID 26205889
- BACKGROUNDSutinen M, Kontunen A, Karjalainen M, Kiiski J, Hannus J, Tolonen T, Roine A, Oksala N. Identification of breast tumors from diathermy smoke by differential ion mobility spectrometry. Eur J Surg Oncol. 2019 Feb;45(2):141-146. doi: 10.1016/j.ejso.2018.09.005. Epub 2018 Oct 15.