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

March 12, 2026 updated by: Vittorio Pedicini, Humanitas Hospital, Italy
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Clinico 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: up to 2 months post-procedure
ablation zone evaluated post-ablation
up to 2 months post-procedure
Technical efficacy
Time Frame: up to 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ablation related complications
Time Frame: up to 12 months
complications and adverse events
up to 12 months
TRIFECA achievement
Time Frame: up to 12 months
Evaluate RFA procedural success based on the TRIFECA benchmark standards
up to 12 months
Treatment efficacy by tumor histotypes
Time Frame: up to 12 months
RFA outcome according to histological subtype
up to 12 months
Distant metastasis-free survival (DMFS)
Time Frame: up to 12 months
evaluate the number of patients who develop distant metastasis after ablation
up to 12 months
Overall Survival
Time Frame: up to 12 months
Time from RFA to death for any cause
up to 12 months
Preserved renal function
Time Frame: up to 12 months
evaluate the impact of RFA on renal function
up to 12 months
Retreatment rate
Time Frame: up to 12 months
number of participants requiring additional RFA
up to 12 months
Time to local tumor progression ( TT-LPP)
Time Frame: up to 12 months
time in months from initial RFA to first detection of local tumor on imaging
up to 12 months
Cost-effectiveness analysis
Time Frame: up to 12 months
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)
Time Frame: up to 12 months
evaluate the number of patients who develop local recurrence or residual tumor growth after ablation
up to 12 months
Cancer Specific Survival (CSS)
Time Frame: up to 12 months
Time from RFA to renal cell carcinoma (RCC)-related death
up to 12 months
Patient reported outcomes
Time Frame: up to 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Humanitas Hospital, Italy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SACMI-Sociedad Aragonesa de Cirugìa Minimamante Invasiva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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