Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients (RASROP-003)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Carcinoma
• Intervention / Treatment: Device: Radiofrequency Ablation (RFA)

• Study Type: Observational
• Enrollment (Estimated): 226

Contacts and Locations

• Study Contact: Name: Vittorio Pedicini, MD; Phone Number: +39335539641; Email: vittorio.pedicini@humanitas.it

Study Locations

• Italy
  • Brescia, Italy
    • Fondazione Poliambulanza Istituto Ospedaliero
    • Contact: Claudio Salemi, MD
    • Principal Investigator: Claudio Salemi, MD
  • Milan, Italy
    • Istituto Europeo di Onclologia ( IEO)
    • Contact: Franco Orsi, MD; Phone Number: +39 0257489060
    • Principal Investigator: Franco Orsi, MD
  • Roma, Italy
    • Policlinico Universitario Campus Bio-Medico
    • Contact: Francesco Grasso, MD
    • Principal Investigator: Francesco Grasso, MD
  • Milano
    • Milan, Milano, Italy
      • Irccs Ospedale San Raffaele
• Spain
  • Barcelona, Spain
    • Hospital Clínico Universitario
    • Principal Investigator: Xavier Serres, MD
    • Contact: Xavier Serres, MD
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
    • Contact: Juan Jose Espejo Herrero, MD
    • Principal Investigator: Juan Jose Espejo Herrero, MD
  • Madrid, Spain
    • Hospital Universitario Fundacion Jimenez Diaz
    • Principal Investigator: Eduardo Crespo, MD
    • Contact: Eduardo Crespo, MD
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro
    • Contact: Santiago Mendez Alonso, MD
    • Principal Investigator: Santiago Mendez Alonso, MD
  • Madrid, Spain
    • Hospital Universitario de Leganés (Severo Ochoa)
    • Contact: Jose Maria Abadal, MD
    • Principal Investigator: Jose Maria Abadal, MD
  • San Sebastián, Spain
    • Hospital Universitario Donostia
    • Contact: Jose Luis Del Cura, MD
    • Principal Investigator: Jose Luis Del Cura, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with primary renal cell carcinomas in stage T1a

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ablation related complications	complications and adverse events	up to 12 months
TRIFECA achievement	Evaluate RFA procedural success based on the TRIFECA benchmark standards	up to 12 months
Treatment efficacy by tumor histotypes	RFA outcome according to histological subtype	up to 12 months
Distant metastasis-free survival (DMFS)	evaluate the number of patients who develop distant metastasis after ablation	up to 12 months
Overall Survival	Time from RFA to death for any cause	up to 12 months
Preserved renal function	evaluate the impact of RFA on renal function	up to 12 months
Retreatment rate	number of participants requiring additional RFA	up to 12 months
Time to local tumor progression ( TT-LPP)	time in months from initial RFA to first detection of local tumor on imaging	up to 12 months
Cost-effectiveness analysis	compare the cost of RFA versus partial nephrectomy in terms of hospitalization days, post-treatment patient management, and retreatment rates.	up to 12 months
Local Tumor Progression (LTP)	evaluate the number of patients who develop local recurrence or residual tumor growth after ablation	up to 12 months
Cancer Specific Survival (CSS)	Time from RFA to renal cell carcinoma (RCC)-related death	up to 12 months
Patient reported outcomes	Pain and quality of life questionaires (QOL) - European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (higher score worst outcome	up to 12 months

Collaborators and Investigators

• Sponsor: Humanitas Hospital, Italy
• Collaborators: SACMI-Sociedad Aragonesa de Cirugìa Minimamante Invasiva

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Radiofrequency Ablation
• Other Study ID Numbers: RASROP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No