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Basal Cell CarcinomaNCT05247710

Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis

An observational study of Basal Cell Carcinoma, run by Tampere University Hospital at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
Punch biopsy
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteFinland
Study dates
9 Dec 2022to Jun 2024
How long will I take part?
6 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with non-superficial basal cell carcinoma and treated in the outpatient clinic of otorhinolaryngology in Tampere University Hospital, Finland.

Who may be able to join

  • Punch biopsy diagnosed basal cell carcinoma.
  • Tumor diameter of 1,5 cm or larger.
  • Operable patient that is willing to participate in the trial.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Anni Salminen, M.D. contact

+358503467184

anni.h.salminen@tuni.fi

Antti Roine, M.D., Ph.D. contact

+358408410698

antti.roine@olfactomics.fi

Finland1 site, 1 recruiting

  • Tampere University Hospital

    Tampere

    Anni Salminen, M.D., anni.m.salminen@pirha.fi

    Niku Oksala, Ph.D., niku.oksala@pirha.fi

    Recruiting

Other trials in Finland

About this study

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.

Read the 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.

Being tested
Punch biopsy
Keywords
Basal cell carcinoma (BCC), Differential mobility spectrometry (DMS), Automatic tissue analysis (ATAS)
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Punch biopsyProcedure or surgery

    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.

Study groups in NCT05247710
Study groupRoleWhat they receive
Patients diagnosed with non-superficial basal cell carcinomaNot described
Receives: Procedure: Punch biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)

  1. 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.

    Measured: Through study completion, an average of 1 year

  2. 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.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start9 Dec 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (estimated)
Target duration
6 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT05247710
Sponsor's protocol ID
R20100L
Status last verified
Apr 2023
First submitted
3 Jan 2022
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9398037

  • 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.

    PubMed 7857111

  • 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.

    PubMed 10411152

  • 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.

    PubMed 2273112

  • 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.

    PubMed 29981388

  • 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.

    PubMed 26205889

  • 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.

    PubMed 30366874

Questions about this trial

What is this clinical trial studying?

An observational study of Basal Cell Carcinoma, run by Tampere University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anni Salminen, M.D. (+358503467184, anni.h.salminen@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of normal and cancerous tissue (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05247710, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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