An observational study in Colorectal Carcinoma, Renal Cancer and Bladder Cancer, sponsored by Amsterdam UMC, location VUmc. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Amsterdam UMC, location VUmc · Observational
The goal of this single-center observational cohort study, based on a registry combining retrospectively and prospectively collected data, is to investigate the short- and long-term effects of irreversible electroporation (IRE) in men and women over the age of 18 who receive IRE for recurrence of pelvic tumors not suitable for other local treatment options such as surgery, thermal ablation, and radiotherapy. The main question it aims to answer is whether IRE is safe in this population, and secondarily, whether it is effective in controlling local tumor recurrence.
Retrospective data from December 2012 to April 2025, followed by prospective collection of new cases.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 27 is below the median of 144 across 75 observational studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
Compared within Anus Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Colorectal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Consecutive patients treated with irreversible electroporation (IRE) for recurrent pelvic tumors at Amsterdam UMC starting from December 2012, identified from a dedicated institutional registry. Patients had recurrent pelvic disease not amenable to other local treatment options (surgery, stereotactic body radiotherapy, or thermal ablation), as determined by a multidisciplinary tumor board including medical oncology, radiation oncology, surgical oncology, diagnostic and interventional radiology, and pathology.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Irreversible electroporation
Incidence and Severity of Adverse Events (CTCAE v5.0)
Safety of IRE, assessed by the rate and severity of adverse events per procedure and per patient, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Assessed up to 5 years.
Incidence and Classification of Nerve Injury (Seddon Classification)
Nerve injuries related to IRE, assessed per procedure and per patient, classified according to Seddon's classification as neurapraxia, axonotmesis, or neurotmesis.
Time frame: Assessed up to 5 years.
Overall survival (OS) per patient.
Overall survival is defined as the time from IRE procedure to the time of death due to any cause or to the last day of follow up (censored).
Time frame: Assessed up to 10 years
Progression-free survival (PFS; per patient analysis)
The time until the date of unequivocal disease progression (local site recurrence or metastatic disease) or death from any cause, whichever occurs first, assessed up to 10 years.
Time frame: Up to 10 years
Distant tumor progression-free survival (DPFS) per patient.
Distant tumor progression-free survival is defined as the time from randomization to the time of unequivocal distant tumor progression.
Time frame: 10 years
Local tumor progression-free survival (LTPFS) per patient and per tumor.
Local tumor progression-free survival is defined as the time from IRE procedure to the time of unequivocal local tumor progression.
Time frame: 10 years
Technical success
Proper placement and operation of the electrodes, the precise delivery of electrical pulses to the targeted tissue, and ensuring the parameters (such as voltage, pulse duration, and frequency) are correctly applied according to the protocol.
Time frame: IRE procedure duration (actual treatment phase): 30 minutes to 2 hours
Length of Post-procedural Hospital Stay
Length of hospital stay following the IRE procedure, in days. Collected to descriptively explore potential associations with lesion and patient characteristics (e.g., lesion type, tumor location).
Time frame: From end of procedure to hospital discharge, assessed up to 30 days.
Tumor markers
Correlation between serum tumor marker levels (e.g., CA19-9, CEA) and radiological tumor response following IRE. Tumor marker dynamics will be explored as potential biomarkers for early treatment efficacy and recurrence.
Time frame: Baseline to 10 years
Plan to share: No
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Amsterdam UMC, location VUmc →