Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis

Recruiting

• Conditions: Basal Cell Carcinoma
• Interventions: Procedure: Punch biopsy

• Registration Number: NCT05247710
• Lead Sponsor: Tampere University Hospital

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 basal cell carcinoma tumor excision surgery.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-21
• Study Start: 2022-12-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with non-superficial basal cell carcinoma	Punch biopsy	-

Primary Outcome Measures

Name	Time	Method
Resolution of normal and cancerous tissue	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.

Secondary Outcome Measures

Name	Time	Method
Differentiation of basal cell carcinoma histopathological sub-types	Through study completion, an average of 1 year	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.
The influence of basal cell carcinoma tumor thickness and infiltration depth on the resolution	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland