Electroporation for Cancer Treatment Real World Registry

Recruiting

• Conditions: Gastrointestinal Cancer; Skin Cancer

• Registration Number: NCT04929912
• Lead Sponsor: Mirai Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-18
• Study Start: 2021-06-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-12-24
• Study Completion: 2036-06-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal London Hospital; 🇬🇧 London, United Kingdom