Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis

Basal Cell Carcinoma Clinical Trial

Official title:

Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247710
• Other study ID #: R20100L
• Status: Recruiting
• Start date: December 9, 2022
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Tampere University Hospital
• Contact: Anni Salminen, M.D.
• Phone: +358503467184
• Email: anni.h.salminen[@]tuni.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma, Basal Cell

Intervention

Procedure:
• Punch biopsy
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.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Olfactomics Oy

Country where clinical trial is conducted

Finland, 

References & Publications (7)

Bichakjian CK, Alam M. Reply to: "Comment on 'Guidelines of care for the management of basal cell carcinoma'". J Am Acad Dermatol. 2018 Nov;79(5):e101. doi: 10.1016/j.jaad.2018.06.051. Epub 2018 Jul 5. No abstract available. — View Citation

Covington 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. — View Citation

English DR, Kricker A, Heenan PJ, Randell PL, Winter MG, Armstrong BK. Incidence of non-melanocytic skin cancer in Geraldton, Western Australia. Int J Cancer. 1997 Nov 27;73(5):629-33. doi: 10.1002/(sici)1097-0215(19971127)73:53.0.co;2-z. — View Citation

Gallagher RP, Hill GB, Bajdik CD, Fincham S, Coldman AJ, McLean DI, Threlfall WJ. Sunlight exposure, pigmentary factors, and risk of nonmelanocytic skin cancer. I. Basal cell carcinoma. Arch Dermatol. 1995 Feb;131(2):157-63. — View Citation

Hannuksela-Svahn A, Pukkala E, Karvonen J. Basal cell skin carcinoma and other nonmelanoma skin cancers in Finland from 1956 through 1995. Arch Dermatol. 1999 Jul;135(7):781-6. doi: 10.1001/archderm.135.7.781. — View Citation

Sexton M, Jones DB, Maloney ME. Histologic pattern analysis of basal cell carcinoma. Study of a series of 1039 consecutive neoplasms. J Am Acad Dermatol. 1990 Dec;23(6 Pt 1):1118-26. doi: 10.1016/0190-9622(90)70344-h. — View Citation

Sutinen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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