Differential Mobility Spectrometry (DMS) Based Oral Tumor Analysis
1 other identifier
observational
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2021
CompletedFirst Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedAugust 14, 2023
June 1, 2023
3.5 years
June 5, 2023
August 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of normal and cancerous tissue identification by differential mobility spectrometry
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.
Through study completion, an average of 1 year
Secondary Outcomes (1)
The influence of oral squamous cell carcinoma tumor thickness and infiltration depth on the resolution
Through study completion, an average of 1 year
Study Arms (1)
Patients diagnosed with oral squamous cell carcinoma
Interventions
Punch biopsy of oral squamous cell carcinoma tumor and a control biopsy of healthy oral mucosa are collected during primary tumor excision surgery from each recruited patient.
Eligibility Criteria
Patients diagnosed with oral squamous cell carcinoma and treated in the outpatient clinic of otorhinolaryngology in Tampere University Hospital, Finland.
You may qualify if:
- Biopsy diagnosed oral squamous cell carcinoma.
- Tumor diameter of 2 cm or larger.
- Operable patient that is willing to participate in the trial.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Olfactomics Oycollaborator
Study Sites (1)
Tampere University Hospital
Tampere, Pirkanmaa, 33521, Finland
Related Publications (8)
P 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: 12946663BACKGROUNDAnderson 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: 25716108BACKGROUNDSutton 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: 12653229BACKGROUNDLubek 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: 28551338BACKGROUNDCovington 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: 26205889BACKGROUNDSutinen 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.
PMID: 30366874BACKGROUND
Related Links
Biospecimen
* Punch biopsy (4mm) of oral squamous cell carcinoma tumor * Control biopsy (4mm) of healthy oral mucosa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Niku Oksala, M.D. Ph.D.
Tampere University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 15, 2023
Study Start
May 25, 2021
Primary Completion
December 1, 2024
Study Completion
June 1, 2025
Last Updated
August 14, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
The research data will be published statistically and anonymously. A single participant can not be identified of the research data. Only the members of the research group will handle the individual participant data (IPD).