Differential Mobility Spectrometry (DMS) Based Skin Tumor Analysis

NCT05247710 | Unknown

• 1 other identifier: R20100L
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Keywords

Basal cell carcinoma (BCC); Differential mobility spectrometry (DMS); Automatic tissue analysis (ATAS)

Outcome Measures

Primary Outcomes (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.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Differentiation of basal cell carcinoma histopathological sub-types

  Through study completion, an average of 1 year

• The influence of basal cell carcinoma tumor thickness and infiltration depth on the resolution

  Through study completion, an average of 1 year

Study Arms (1)

Patients diagnosed with non-superficial basal cell carcinoma

Procedure: Punch biopsy

Interventions

Punch biopsy PROCEDURE

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.

Patients diagnosed with non-superficial basal cell carcinoma

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead
• Olfactomics Oy: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, Finland

RECRUITING

Related Publications (7)

• 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.

  PMID: 9398037 BACKGROUND

• 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.

  PMID: 7857111 BACKGROUND

• 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.

  PMID: 10411152 BACKGROUND

• 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.

  PMID: 2273112 BACKGROUND

• 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.

  PMID: 29981388 BACKGROUND

• 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.

  PMID: 26205889 BACKGROUND

• 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.

  PMID: 30366874 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

* Punch biopsy (4 mm) of basal cell carcinoma tumor * Control biopsy (4 mm) of healthy skin

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Niku Oksala, M.D., Ph.D.

  Tampere University Hospital

  STUDY DIRECTOR

Central Study Contacts

Anni Salminen, M.D.

CONTACT

+358503467184; anni.h.salminen@tuni.fi

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

CONTACT

+358408410698; antti.roine@olfactomics.fi

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 21, 2022
• Study Start: December 9, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)