NCT04259658

Histopathologic Effect of Calcium Electroporation on Cancer in the Skin

Phase II Investigation of the Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.

Detailed description

In this non randomized phase II study, we will explore histopathological tumour cell death mechanisms in 24 patients with breast cancer metastases or 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.

Conditions

• Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Calcium electroporation	Patients with cutaneous metastases will be treated with calcium electroporation.

Timeline

• Start date: 2020-04-20
• Primary completion: 2022-10-19
• Completion: 2023-07-27
• First posted: 2020-02-06
• Last updated: 2023-10-03

Locations

1 site across 1 country: Denmark