Clinical trial NCT05247710: Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis
Official title: Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Basal Cell Carcinoma
Keywords: Basal cell carcinoma (BCC)
Differential mobility spectrometry (DMS)
Automatic tissue analysis (ATAS)
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Olfactomics Oy
First posted: 2022-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with non-superficial basal cell carcinoma and treated in the outpatient clinic of otorhinolaryngology in Tampere University Hospital, Finland.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resolution of normal and cancerous tissue
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Differentiation of basal cell carcinoma histopathological sub-types
timeFrame: Through study completion, an average of 1 year
measure: The influence of basal cell carcinoma tumor thickness and infiltration depth on the resolution
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Niku Oksala, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
citation: 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.
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.
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.