International Registry of Treatments for Localized Kidney Tumors
This study is an international registry looking at different ways to treat kidney cancer that is localized (meaning it hasn't spread). It's comparing several approaches: Partial Nephrectomy (removing only the tumor), Radical Nephrectomy (removing the whole kidney), Ablation therapy (destroying the tumor with heat or cold), and Active Surveillance (watching the tumor closely with scans and treating it later if needed). The study wants to see how effective Partial Nephrectomy is compared to Radical Nephrectomy in preventing the cancer from coming back, and how it affects heart problems and survival over 5 years. It also looks at how robotic surgery for Partial Nephrectomy affects recovery. You might be able to join if you are 18 or older, have a kidney tumor that can be treated, and agree to participate. This study is observational, meaning doctors will watch what happens to people receiving these treatments in real-world settings.
- Study design
- This is an observational study that will collect data from 10,000 patients at 50 hospitals worldwide over two years.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years after their treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
At a glance
Conditions
NCT05363657
Where you'd take part
This study runs at 37 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Amsterdam University Medical Centers
Amsterdam, Netherlandsstudy coordinator listed
Recruiting
AOUI Verona
Verona, Italystudy coordinator listed
Recruiting
Azienda Ospedaliera Policlinico "G. Martino", Università di Messina.
Messina, Italystudy coordinator listed
Recruiting
Bristol Urological Institute
Bristol, United Kingdomstudy coordinator listed
Recruiting
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital
Florence, Italystudy coordinator listed
Recruiting
Division of Urology, University of Genoa,Policlinico San Martino Hospital
Genova, Italystudy coordinator listed
Recruiting
European Health Center
Otwock, Polandstudy coordinator listed
Recruiting
Fundaciò Puigvert
Barcelona, Spainstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Andrea Minervini, Prof. · PRINCIPAL_INVESTIGATOR · Dipartimento di Medicina Clinica e Sperimentale Via o Piazza Largo Brambilla 3 - 50134 Firenze (Italy)
Who to contact
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Inclusion
Exclusion
What this trial measures
- To test the effectiveness of partial nephrectomy for the treatment of localized renal tumors (T1-T2N0M0) with regards to recurrence-free survival and cardiovascular accidents and mortality in comparison to radical nephrectomy?Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years
The preoperative characteristics of the patients will be specifically evaluated to calculate any heterogeneity between the two groups. In detail, anthropometric and comorbidity features, previous abdominal surgery, blood chemistry values, blood pressure, smoking habit, preoperative life expectancy, and frailty grade will be assessed. Imaging features of the tumor will be considered, including the characteristics necessary for the calculation of the PADUA, R.E.N.A.L., and Contact-Surface-Area scores. Patients with a node-positive or metastatic disease diagnosed with conventional imaging (CT scan/MRI) will be excluded. Intra-operative and post-operative outcomes will be evaluated. Histopathological features of the tumor will be assessed. Patients will be followed up with conventional imaging according to the International guidelines (ultrasound, CT, MRI). Serum creatinine, platelets and estimated glomerular function (eGFR), the onset of cardiovascular adverse events will be registered.
- To test the effectiveness of robotic approach in partial nephrectomy to increase the "Trifecta" rate after nephron-sparing surgery in patients with T1-T2N0M0 renal tumors.Assesment of the "Trifecta" outcome will be performed at 12 months from the surgical intervention. Time frame: 1 year.
"Trifecta" rate is defined as 1) Absence of intraoperative and postoperative surgical complications; 2) absence of positive surgical margins or recurrences on tumor resection site during a 5-year follow-up; 3) Absence of clinically significant renal function loss at one year after surgery. Renal function will be evaluated using the estimated glomerular filtration rate (eGFR) in ml/min/1.73 m\^2 using the CKD-EPI Creatinine Equation (2021). A clinically significant loss will be considered if \>25% from eGFR at baseline. The "Trifecta" outcome will be evaluated one year from surgery.