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ClinicalTrials.gov ID

NCT07465458

Lead Sponsor

Humanitas Hospital, ItalyOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

226Estimated

Last Update Posted

Mar 16, 2026Actual

Start Date

Mar 2026Estimated

Primary Completion Date

Mar 2028Estimated

Completion Date

Jun 2028Estimated

Official Title

Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients

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.

• Renal Carcinoma

• Radiofrequency Ablation (RFA)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Humanitas Hospital, ItalyOTHER

Collaborators

SACMI-Sociedad Aragonesa de Cirugìa Minimamante InvasivaUNKNOWN

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