Histopathologic Effect of Calcium Electroporation on Cancer in the Skin
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- STATUS
- Recruiting
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- participants needed
- 24
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- sponsor
- Zealand University Hospital
Summary
In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.
Description
In this non randomized phase II study, we will explore histopathological tumour cell death mechanisms in 12 patients with breast cancer metastases and 12 patients with other cutaneous or subcutaneous malignancy. The primary endpoint of the biopsy study is to evaluate differences in tumour infiltrating lymphocyte (TIL) population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to samples taken on the day of treatment before the calcium electroporation procedure. TIL content in biopsies will be evaluated by pathological examination and specified in percent of cells. Patients will be followed up to 3 months and depending on number of treated tumors, biopsies will be taken at different timepoints after one or two treatments with calcium electroporation. Other analyses will include differences regarding tumour type, immune marker expression levels over time, vascular effects and regressive changes as well as examining changes in systemic immunological markers.
Details
| Condition | Cancer |
|---|---|
| Age | 18years - 100years |
| Treatment | Calcium electroporation |
| Clinical Study Identifier | NCT04259658 |
| Sponsor | Zealand University Hospital |
| Last Modified on | 19 February 2024 |
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