Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis

Study Overview
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Brief Summary
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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 basal cell carcinoma tumor excision surgery.

Detailed Description
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Basal cell carcinoma (BCC) is the most common cancer in Caucasians and the average risk of developing BCC is approximately 30% (1,2). In Finland, BCC is the most common cancer and the incidence of BCC is approximately 49/100 000 in men and 45/100 000 in women (3). There are several types of BCC (4) of which superficial type can be managed with non-operative treatment. All the other types of BCC (micronodular, nodular, infiltrative) require operative treatment which means surgical removal of the tumor with a few millimeters healthy skin margin (5). The aim of the operative treatment is to remove the tumor entirely so that the healthy skin margins are as sparing as possible and that the functional and cosmetic outcomes are as satisfactory as possible. Margin positiveness leads to one or more reoperations which increase the risk of surgical complications. 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 (6,7). The objective of the trial is to test whether it is possible to identify BCC from normal skin by using ATAS. A 4mm punch biopsy of BCC tumor and a control biopsy of healthy skin will be collected from 30 - 40 patients undergoing BCC tumor excision. The biopsies will be examined in the research laboratory with ATAS to test tissue recognition.

Official Title
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Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Procedure: Punch biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Punch biopsy diagnosed basal cell carcinoma. Tumor diameter of 1,5 cm or larger. Operable patient that is willing to participate in the trial. Exclusion Criteria: Tumor diameter of less than 1,5 cm. Patient that is unsuitable to take part in the trial, for example, has a tendency to develop keloids. 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 consent to take part in the trial.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with non-superficial basal cell carcinoma<br> | Procedure: Punch biopsy<br>* Punch biopsy of basal cell carcinoma tumor and a control biopsy of healthy skin are collected during primary tumor excision surgery from each recruited patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of normal and cancerous tissue | 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 |
| --- | --- | --- |
| Differentiation of basal cell carcinoma histopathological sub-types | There are several histopathological sub-types of BCC which have a different kind of tumor growth. It is possible that the differences in tumor histopathology have an effect on the resolution of tissue types. | Through study completion, an average of 1 year | 
| The influence of basal cell carcinoma tumor thickness and infiltration depth on the resolution | BCC can grow nodularly forming a round-shape tumor, infiltratively through the layers of the skin causing ulcers and/or flatly. Each BCC tumor has one or more features in tumor growth. 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 tissue types. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Basal cell carcinoma (BCC), Differential mobility spectrometry (DMS), Automatic tissue analysis (ATAS)