Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients
RASROP-003
1 other identifier
observational
226
2 countries
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 6, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
March 16, 2026
March 1, 2026
2 years
March 6, 2026
March 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Technical success
ablation zone evaluated post-ablation
up to 2 months post-procedure
Technical efficacy
Abscence of tumor recurrence within the margin of the ablation zone or viable residual tumor on follow-up imaging
up to 12 months
Secondary Outcomes (12)
Ablation related complications
up to 12 months
TRIFECA achievement
up to 12 months
Treatment efficacy by tumor histotypes
up to 12 months
Local Tumor Progression (LTP)
up to 12 months
Distant metastasis-free survival (DMFS)
up to 12 months
- +7 more secondary outcomes
Interventions
Minimally invasive RFA in T1a renal carcinomas
Eligibility Criteria
Patients with primary renal cell carcinomas in stage T1a
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
IRCCS Ospedale San Raffaele
Milan, Milano, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
Istituto Europeo di Onclologia ( IEO)
Milan, Italy
Policlinico Universitario Campus Bio-Medico
Roma, Italy
Hospital Clínico Universitario
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario de Leganés (Severo Ochoa)
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Universitario Donostia
San Sebastián, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 6, 2026
First Posted
March 12, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share