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NCT Number: NCT07465458

Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele, Milan, Milano, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency ablation (RFA)

Device

Minimally invasive RFA in T1a renal carcinomas

Other names: Next-generation Radiofrequency Generator (Cambridge Interventional)

Primary outcomes

  1. Technical success

    Time frame: up to 2 months post-procedure

    ablation zone evaluated post-ablation

  2. 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

Secondary outcomes

  1. Ablation related complications

    Time frame: up to 12 months

    complications and adverse events

  2. TRIFECA achievement

    Time frame: up to 12 months

    Evaluate RFA procedural success based on the TRIFECA benchmark standards

  3. Treatment efficacy by tumor histotypes

    Time frame: up to 12 months

    RFA outcome according to histological subtype

  4. 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

  5. Distant metastasis-free survival (DMFS)

    Time frame: up to 12 months

    evaluate the number of patients who develop distant metastasis after ablation

  6. Overall Survival

    Time frame: up to 12 months

    Time from RFA to death for any cause

  7. Cancer Specific Survival (CSS)

    Time frame: up to 12 months

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

  8. Preserved renal function

    Time frame: up to 12 months

    evaluate the impact of RFA on renal function

  9. Retreatment rate

    Time frame: up to 12 months

    number of participants requiring additional RFA

  10. 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

  11. 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

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Vittorio Pedicini, MD

CONTACT

[email protected]

+39335539641

Sponsors and collaborators

Lead sponsor

Humanitas Hospital, Italy

Other

Collaborators

  • SACMI-Sociedad Aragonesa de Cirugìa Minimamante Invasiva

Registry information

Acronym: RASROP-003

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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