Electroporation for Cancer Treatment Real World Registry

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.

Recruiting

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Key information

Conditions

Skin Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal London Hospital

London, E1 1FR, United Kingdom

Location status: Recruiting

Location contact

Greme Moir

CONTACT

Greme Moir

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Time frame: 3 months, 12 months, 3 years, 5 years

A response evaluation will be conducted at standard of care follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Declan Soden

CONTACT

[email protected]

SEAN H KINSELLA

CONTACT

[email protected]

+353 91 442 498

Sponsors and collaborators

Lead sponsor

Mirai Medical

Industry

Registry information

Acronym: PIONEER

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2036
First posted: Jun 18, 2021
Registry last updated: Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting