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NCT04929912 Clinical Trial

Electroporation for Cancer Treatment Real World Registry

Skin Cancer Clinical Trial

— PIONEER  

Official title:
Electroporation for Cancer Treatment Real World Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04929912
Other study ID # CIP-21-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 24, 2021
Est. completion date June 24, 2036

Study information
Verified date June 2021
Source Mirai Medical
Contact SEAN H KINSELLA
Phone +353 91 442 498
Email sean@mirai-medical.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date June 24, 2036
Est. primary completion date December 24, 2026
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal London Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Mirai Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events (CTCAE) 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)		 5 years
Secondary Response Evaluation Criteria in Solid Tumours (RECIST) A response evaluation will be conducted at standard of care follow up 3 months, 12 months, 3 years, 5 years
Secondary Modified FACE-Q evaluation for Skin Cancers Cosmesis evaluation will be recorded for skin cancers at standard of care follow up 3 months, 12 months, 3 years, 5 years
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