NCT07465458

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
2 countries

10 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Jun 2028

Study Start

First participant enrolled

March 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 6, 2026

Last Update Submit

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

Also known as: Next-generation Radiofrequency Generator (Cambridge Interventional)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy

Location

Istituto Europeo di Onclologia ( IEO)

Milan, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, Italy

Location

Hospital Clínico Universitario

Barcelona, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario de Leganés (Severo Ochoa)

Madrid, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Spain

Location

Hospital Universitario Donostia

San Sebastián, Spain

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Vittorio Pedicini, MD

CONTACT

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

Locations