Gastrointestinal Cancer, Skin Cancer
Conditions
Keywords
Pulsed Electric Fields, Reversible Electroporation, Electrochemotherapy, Ca-Electroporation
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.
Interventions
None listed
Sponsors
Mirai Medical
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
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
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (CTCAE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Response Evaluation Criteria in Solid Tumours (RECIST) | 3 months, 12 months, 3 years, 5 years | A response evaluation will be conducted at standard of care follow up |
Countries
United Kingdom
Contacts
Primary ContactSEAN H KINSELLA
Backup ContactDeclan Soden
Outcome results
None listed