Electroporation for Cancer Treatment Real World Registry
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Skin Cancer
- Sponsor
- Mirai Medical
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events (CTCAE)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This registry aims to assess real-world long-term disease outcomes for patients treated using reversible electroporation and a chemotherapeutic or calcium; in particular tumour response rates and recurrence rates. The study also aims to characterise side effects and the occurrence of Adverse Events and their relationship to the treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any patient who has been treated using Calcium Electroporation
- •Any patient who has been treated using Electrochemotherapy
- •Patients must be mentally capable of understanding the information given
- •Patients must give written informed consent.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events (CTCAE)
Time Frame: 5 years
Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE)
Secondary Outcomes
- Response Evaluation Criteria in Solid Tumours (RECIST)(3 months, 12 months, 3 years, 5 years)