Histopathologic Effect of Calcium Electroporation on Cancer in the Skin

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Zealand University Hospital
Updated on 19 February 2024
cancer
calcium
metastasis
hormone therapy
endocrine therapy

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 18-100 years
Treatment Calcium electroporation
Clinical Study IdentifierNCT04259658
SponsorZealand University Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Trial subject must be able to understand the participant information
Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology
The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.)
The patient can undergo radiation therapy during the study period, provided that the treatment field does not involve the treated area
Performance status ECOG/WHO 2
At least one cutaneous or subcutaneous tumour measuring at least 5 mm
Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch.)
Signed informed consent

Exclusion Criteria

Pregnancy or lactation
Allergy to local anaesthesia
Clear my responses

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