An observational study in Basal Cell Carcinoma, sponsored by Tampere University Hospital. Status unknown at 1 site in Finland. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Tampere University Hospital · Observational
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.
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.
364 studies on the registry are indexed under Carcinoma, Basal Cell; 66 are open to participants now.
This study's planned enrollment of 40 is below the median of 138 across 92 observational studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with non-superficial basal cell carcinoma and treated in the outpatient clinic of otorhinolaryngology in Tampere University Hospital, Finland.
Exclusion Criteria:
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.
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
Plan to share: No
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Tampere University Hospital