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| Name | Class |
|---|---|
| SACMI-Sociedad Aragonesa de Cirugìa Minimamante Invasiva | UNKNOWN |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation (RFA) | Device | Minimally invasive RFA in T1a renal carcinomas |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ablation related complications | complications and adverse events | up to 12 months |
| TRIFECA achievement | Evaluate RFA procedural success based on the TRIFECA benchmark standards |
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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:
Exclusion Criteria:
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Patients with primary renal cell carcinomas in stage T1a
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vittorio Pedicini, MD | Contact | +39335539641 | vittorio.pedicini@humanitas.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | Milano | Italy | |||
| Fondazione Poliambulanza Istituto Ospedaliero |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| up to 12 months |
| Treatment efficacy by tumor histotypes | RFA outcome according to histological subtype | up to 12 months |
| Local Tumor Progression (LTP) | evaluate the number of patients who develop local recurrence or residual tumor growth after ablation | up to 12 months |
| Distant metastasis-free survival (DMFS) | evaluate the number of patients who develop distant metastasis after ablation | up to 12 months |
| Overall Survival | Time from RFA to death for any cause | up to 12 months |
| Cancer Specific Survival (CSS) | Time from RFA to renal cell carcinoma (RCC)-related death | up to 12 months |
| Preserved renal function | evaluate the impact of RFA on renal function | up to 12 months |
| Retreatment rate | number of participants requiring additional RFA | up to 12 months |
| Time to local tumor progression ( TT-LPP) | time in months from initial RFA to first detection of local tumor on imaging | up to 12 months |
| 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 | up to 12 months |
| Cost-effectiveness analysis | compare the cost of RFA versus partial nephrectomy in terms of hospitalization days, post-treatment patient management, and retreatment rates. | up to 12 months |
| Brescia |
| Italy |
|
| Istituto Europeo di Onclologia ( IEO) | Milan | Italy |
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| Policlinico Universitario Campus Bio-Medico | Roma | Italy |
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| Hospital Clínico Universitario | Barcelona | Spain |
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| Hospital Universitario Reina Sofía | Córdoba | Spain |
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| Hospital Universitario de Leganés (Severo Ochoa) | Madrid | Spain |
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| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain |
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| Hospital Universitario Puerta de Hierro | Madrid | Spain |
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| Hospital Universitario Donostia | San Sebastián | Spain |
|
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |