Differential Mobility Spectrometry (DMS) Based Oral Tumor Analysis

August 10, 2023 updated by: Tampere University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Oral squamous cell carcinoma is the sixth common carcinoma and the cause of 1-2% of cancer related deaths in the world. The incidence of oral squamous cell carcinoma was 255 cases in Finland and 742 270 cases worldwide in year 2015. The number of cases per year has been increasing. The approximate age of tumor occurrence is usually between 60 - 70 years. The 5-year survival rate of all diagnosed oral squamous cell carcinoma cases in Finland during the years between 2014 and 2016 was 67% for women and 61% for men.

Early diagnostics is relevant, since oral squamous cell carcinoma tumors have a tendency to grow rapidly and metastasize early to regional lymphnodes and later on to lungs, liver and bones. Typical locations of the tumor are tongue, gums and sole of mouth.

The primary treatment option for oral squamous cell carcinoma is surgical removal of the tumor with 0,5 - 1cm healthy tissue margin. The aim of the operation is to remove the tumor entirely so that the healthy tissue margins are as sparing as possible and that the functional and cosmetic outcomes are as satisfactory as possible. Sufficient healthy tissue margin is one of the most important prognostic factors. Nevertheless, there is only little evidence based knowledge of sufficient healthy tissue margins.

Differential mobility spectrometry (DMS) based application called automatic tissue analysis (ATAS) can be utilized to identify tumor cells from healthy tissue. Tissue identification is done by analyzing tissue smoke that is generated by the use of an electrosurgical instrument called diathermy.

The objective of the trial is to test whether it is possible to identify oral squamous cell carcinoma tissue from normal oral mucosa by using ATAS. A 4mm punch biopsy of an oral squamous cell carcinoma tumor and a control biopsy of healthy oral mucosa will be collected from 30 - 40 patients undergoing oral tumor excision. The biopsies will be examined in the research laboratory with ATAS to test tissue recognition.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33521
        • Recruiting
        • Tampere University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with oral squamous cell carcinoma and treated in the outpatient clinic of otorhinolaryngology in Tampere University Hospital, Finland.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with oral squamous cell carcinoma
Procedure: Punch biopsy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of normal and cancerous tissue identification by differential mobility spectrometry
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The influence of oral squamous cell carcinoma tumor thickness and infiltration depth on the resolution
Time Frame: Through study completion, an average of 1 year
The overall thickness of the tumor and the infiltration depth of the tumor, both presented in millimetres, can have an effect on the resolution of cancerous tissue.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Olfactomics Oy

Investigators

  • Study Director: Niku Oksala, M.D. Ph.D., Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R20100L(a)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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