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Renal CarcinomaRASROP-003NCT07465458

Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients

An observational study of Renal Carcinoma, run by Humanitas Hospital, Italy at 10 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Carcinoma
What is being tested?
Radiofrequency Ablation (RFA)
Type of treatment
Medical device
How many people
226 participants
Where
10 sitesin 2 countries
Study dates
Mar 2026to Jun 2028
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with primary renal cell carcinomas in stage T1a

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Vittorio Pedicini, MD contact

+39335539641

vittorio.pedicini@humanitas.it

10 sites in 2 countries

Spain6 sites

  • Hospital Clínico Universitario

    Barcelona

    Xavier Serres, MD

    Xavier Serres, MD

  • Hospital Universitario Reina Sofía

    Córdoba

    Juan Jose Espejo Herrero, MD

    Juan Jose Espejo Herrero, MD

  • Hospital Universitario de Leganés (Severo Ochoa)

    Madrid

    Jose Maria Abadal, MD

    Jose Maria Abadal, MD

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid

    Eduardo Crespo, MD

    Eduardo Crespo, MD

  • Hospital Universitario Puerta de Hierro

    Madrid

    Santiago Mendez Alonso, MD

    Santiago Mendez Alonso, MD

  • Hospital Universitario Donostia

    San Sebastián

    Jose Luis Del Cura, MD

    Jose Luis Del Cura, MD

Other trials in Spain

Italy4 sites

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia

    Claudio Salemi, MD

    Claudio Salemi, MD

  • IRCCS Ospedale San Raffaele

    Milan, Milano

  • Istituto Europeo di Onclologia ( IEO)

    Milan

    Franco Orsi, MD, +39 0257489060

    Franco Orsi, MD

  • Policlinico Universitario Campus Bio-Medico

    Roma

    Francesco Grasso, MD

    Francesco Grasso, MD

Other trials in Italy

About this study

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.

Conditions
Renal Carcinoma
Being tested
Radiofrequency Ablation (RFA)
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiofrequency Ablation (RFA)Device

    Also called Next-generation Radiofrequency Generator (Cambridge Interventional)

    Minimally invasive RFA in T1a renal carcinomas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical success

    ablation zone evaluated post-ablation

    Measured: up to 2 months post-procedure

  2. Technical efficacy

    Abscence of tumor recurrence within the margin of the ablation zone or viable residual tumor on follow-up imaging

    Measured: up to 12 months

Secondary outcomes (12)

  1. Ablation related complications

    complications and adverse events

    Measured: up to 12 months

  2. TRIFECA achievement

    Evaluate RFA procedural success based on the TRIFECA benchmark standards

    Measured: up to 12 months

  3. Treatment efficacy by tumor histotypes

    RFA outcome according to histological subtype

    Measured: up to 12 months

  4. Local Tumor Progression (LTP)

    evaluate the number of patients who develop local recurrence or residual tumor growth after ablation

    Measured: up to 12 months

  5. Distant metastasis-free survival (DMFS)

    evaluate the number of patients who develop distant metastasis after ablation

    Measured: up to 12 months

  6. Overall Survival

    Time from RFA to death for any cause

    Measured: up to 12 months

  7. Cancer Specific Survival (CSS)

    Time from RFA to renal cell carcinoma (RCC)-related death

    Measured: up to 12 months

  8. Preserved renal function

    evaluate the impact of RFA on renal function

    Measured: up to 12 months

  9. Retreatment rate

    number of participants requiring additional RFA

    Measured: up to 12 months

  10. Time to local tumor progression ( TT-LPP)

    time in months from initial RFA to first detection of local tumor on imaging

    Measured: up to 12 months

  11. 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

    Measured: up to 12 months

  12. Cost-effectiveness analysis

    compare the cost of RFA versus partial nephrectomy in terms of hospitalization days, post-treatment patient management, and retreatment rates.

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
226 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07465458
Sponsor's protocol ID
RASROP
Acronym
RASROP-003
Status last verified
Mar 2026
First submitted
6 Mar 2026
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Carcinoma, run by Humanitas Hospital, Italy at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vittorio Pedicini, MD (+39335539641, vittorio.pedicini@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success (time frame: up to 2 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07465458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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