Renal Carcinoma
Conditions
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.
Interventions
DEVICERadiofrequency Ablation (RFA)
Minimally invasive RFA in T1a renal carcinomas
Sponsors
Humanitas Hospital, Italy
SACMI-Sociedad Aragonesa de Cirugìa Minimamante Invasiva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | up to 2 months post-procedure | ablation zone evaluated post-ablation |
| Technical efficacy | up to 12 months | Abscence of tumor recurrence within the margin of the ablation zone or viable residual tumor on follow-up imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ablation related complications | up to 12 months | complications and adverse events |
| TRIFECA achievement | up to 12 months | Evaluate RFA procedural success based on the TRIFECA benchmark standards |
| Treatment efficacy by tumor histotypes | up to 12 months | RFA outcome according to histological subtype |
| Local Tumor Progression (LTP) | up to 12 months | evaluate the number of patients who develop local recurrence or residual tumor growth after ablation |
| Distant metastasis-free survival (DMFS) | up to 12 months | evaluate the number of patients who develop distant metastasis after ablation |
| Overall Survival | up to 12 months | Time from RFA to death for any cause |
| Cancer Specific Survival (CSS) | up to 12 months | Time from RFA to renal cell carcinoma (RCC)-related death |
| Preserved renal function | up to 12 months | evaluate the impact of RFA on renal function |
| Retreatment rate | up to 12 months | number of participants requiring additional RFA |
| Time to local tumor progression ( TT-LPP) | up to 12 months | time in months from initial RFA to first detection of local tumor on imaging |
| Patient reported outcomes | 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 |
| Cost-effectiveness analysis | up to 12 months | compare the cost of RFA versus partial nephrectomy in terms of hospitalization days, post-treatment patient management, and retreatment rates. |
Countries
Italy, Spain
Contacts
CONTACTVittorio Pedicini, MD
Outcome results
None listed