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Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients

ConditionRenal Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHumanitas Hospital, Italy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Patients with primary renal cell carcinomas in stage T1a

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiofrequency Ablation (RFA)

    Device

    Minimally invasive RFA in T1a renal carcinomas

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Technical success

ablation zone evaluated post-ablation

Time frame
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

Time frame
up to 12 months

Secondary outcomes

1

Ablation related complications

complications and adverse events

Time frame
up to 12 months
2

TRIFECA achievement

Evaluate RFA procedural success based on the TRIFECA benchmark standards

Time frame
up to 12 months
3

Treatment efficacy by tumor histotypes

RFA outcome according to histological subtype

Time frame
up to 12 months
4

Local Tumor Progression (LTP)

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

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Humanitas Hospital, Italy

Lead sponsor

SACMI-Sociedad Aragonesa de Cirugìa Minimamante Invasiva

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: