Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiofrequency Ablation (RFA).
- Who it may be relevant to
- Registry conditions: Renal Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This observational study is designed to expand the current database available in the literature and the existing knowledge on the outcomes and safety of radiofrequency ablation (RFA) for the treatment of primary renal cell carcinomas in stage T1a. All interventions and subsequent follow-ups are clinical decisions are independent of the study, given its observational nature.
Interventions
- Device Radiofrequency Ablation (RFA)
Minimally invasive RFA in T1a renal carcinomas
Primary outcome measures
- Technical success [Time frame: up to 2 months post-procedure]
- Technical efficacy [Time frame: up to 12 months]
Secondary outcome measures (12)
- Ablation related complications [Time frame: up to 12 months]
- TRIFECA achievement [Time frame: up to 12 months]
- Treatment efficacy by tumor histotypes [Time frame: up to 12 months]
- Local Tumor Progression (LTP) [Time frame: up to 12 months]
- Distant metastasis-free survival (DMFS) [Time frame: up to 12 months]
- Overall Survival [Time frame: up to 12 months]
- Cancer Specific Survival (CSS) [Time frame: up to 12 months]
- Preserved renal function [Time frame: up to 12 months]
- Retreatment rate [Time frame: up to 12 months]
- Time to local tumor progression ( TT-LPP) [Time frame: up to 12 months]
- Patient reported outcomes [Time frame: up to 12 months]
- Cost-effectiveness analysis [Time frame: up to 12 months]
Eligibility criteria
Patient selection criteria will be those typically established by each participating center t with T1a primary renal tumors for which a Multidisciplinary Tumor Board has indicated as candidates for treatment with radiofrequency ablation.I
Inclusion criteria
- Age ≥18 years
- Signed informed consent approved by the Ethics Committee prior to the ablation procedure.
- RCC in stage T1a (size <4 cm), single or multiple, histologically demonstrated by percutaneous biopsy before or within 30 days prior to ablation
- Absence of comorbidities that contraindicate treatment
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 at baseline screening.
Exclusion criteria
- No specific exclusion criteria are established for this clinical registry due to its observational nature. Each center will apply its own criteria according to its routine clinical practice.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 6 centers
- Hospital Clínico Universitario — Barcelona
- Hospital Universitario Reina Sofía — Córdoba
- Hospital Universitario de Leganés (Severo Ochoa) — Madrid
- Hospital Universitario Fundación Jiménez Díaz — Madrid
- Hospital Universitario Puerta de Hierro — Madrid
- Hospital Universitario Donostia — San Sebastián
Italy · 4 centers
- IRCCS Ospedale San Raffaele — Milan
- Fondazione Poliambulanza Istituto Ospedaliero — Brescia
- Istituto Europeo di Onclologia ( IEO) — Milan
- Policlinico Universitario Campus Bio-Medico — Roma
Identifiers
NCT: NCT07465458 · RASROP