Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis

Last updated: July 4, 2023
Sponsor: Tampere University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Basal Cell Carcinoma

Carcinoma

Warts

Treatment

Punch biopsy

Clinical Study ID

NCT05247710
R20100L
  • Ages 40-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 todevelop keloids.
  • Patient that is unwilling to take part in the trial.
  • Patient that is not able to understand given information concerning the trial or togive consent to take part in the trial.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Punch biopsy
Phase:
Study Start date:
December 09, 2022
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Tampere University Hospital

    Tampere,
    Finland

    Active - Recruiting

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