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International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
Sponsor: Azienda Ospedaliero-Universitaria Careggi
Summary
Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (\<7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Nonetheless, indications, approaches, techniques for PN, and correct reporting of outcomes, are still a matter of great debate within the urology community. Concurrently, case-report series suggested that alternative strategies for the treatment of localized renal tumors (ablation techniques (AT), watchful waiting (WW), active surveillance (AS)) could be feasible with acceptable oncologic outcomes in particular settings of patients with localized renal tumors. In this complex clinical scenario, the role surgeon-related and environmental factors (such as surgical experience, hospital resources, countries' social background and performance of health system) are important to address the best personalized approach in patients with renal tumors. In the light of current evidence, many unsolved questions still remain and many unmet needs must be addressed. In particular, 1) the risk-benefit trade-offs between PN and RN for anatomically complex renal localized tumors; 2) the definition of evidence-based strategies to tailor the management strategy (AT vs WW vs AS vs surgery) in different subset of patients with particular clinical conditions (i.e. old, frail, comorbid patients); and 3) the definition of evidence-based recommendations to adapt surgical approach (open vs laparoscopic vs robotic) and resection techniques to different patient-, tumor-, and surgeon-specific characteristics. To meet the challenges, to overcome the limitations of current kidney cancer literature (such as the retrospective study design, potential risk of biases, and heterogeneous follow-up of most series), and to provide high-quality evidence for future development of effective clinical practice Guidelines, we designed the international REgistry of COnservative or Radical treatment of localized kiDney tumors (i-RECORD) Project. The expected impact of the i-RECORD project is to provide robust evidence on the leading clinical and environmental factors driving selection of the management strategy in patients with kidney cancer, and the differential impact of different management strategies (including AS, WW, AT, PN and RN) on functional, perioperative and oncological outcomes, as well as quality of life assessment, at a mid-long term follow-up (5-10 years).
Official title: International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
10000
Start Date
2022-01-10
Completion Date
2028-12-31
Last Updated
2022-05-06
Healthy Volunteers
No
Conditions
Interventions
Partial Nephrectomy (PN)
Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Radical Nephrectomy (RN)
Surgical removal of the affected kidney. Adrenal removal can be performed according to surgeon choice and clinical characteristics of the renal tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Ablation therapy (AT)
The procedure of tumor ablation performed with radiofrequency or cryoablation. The procedure can be performed either with a laparoscopic approach or percutaneous access.
Active Surveillance (AS)
Active surveillance is defined as the initial management including the monitoring of renal tumor size by serial imaging with delayed treatment in case of progression.
Locations (37)
Institute of Urology, University of Southern California.
Los Angeles, California, United States
University of California San Diego, Moores Cancer Center
San Diego, California, United States
Stanford University
Stanford, California, United States
Loyola University Medical Center, Edward Hines VA Hospital
Chicago, Illinois, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
VCU Health System
Richmond, Virginia, United States
Swedish Hospital
Seattle, Washington, United States
Medical University of Vienna, Vienna General Hospital
Vienna, Austria
University of Bruxelles
Brussels, Belgium
University Hospitals Leuven
Leuven, Belgium
Onze Lieve Vrouw Hospital
Leuven, Belgium
Santa Casa da Misericórdia de Fortaleza
Fortaleza, Brazil
University of Patras
Pátrai, Greece
Urology, Andrology & Kidney Transplantation Unit, University of Bari
Bari, Italy
Policlinico S. Orsola Malpighi
Bologna, Italy
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital
Florence, Italy
Policlinico Riuniti, Università di Foggia.
Foggia, Italy
Division of Urology, University of Genoa,Policlinico San Martino Hospital
Genova, Italy
Azienda Ospedaliera Policlinico "G. Martino", Università di Messina.
Messina, Italy
San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital
Milan, Italy
Policlinico Istituto Europeo di Oncologia (IEO)
Milan, Italy
Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale"
Naples, Italy
Institute Oncology Veneto (IOV)
Padova, Italy
Humanitas Hospital
Rozzano, Italy
Università degli Studi di Torino, Ospedale S. Luigi Gonzaga.
Torino, Italy
Università degli studi di Torino, Ospedale Molinette
Torino, Italy
AOUI Verona
Verona, Italy
Jikei University School of Medicine
Tokyo, Japan
Amsterdam University Medical Centers
Amsterdam, Netherlands
European Health Center
Otwock, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Warsaw, Poland
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia
NG Teng Fong General Hospital
Singapore, Singapore
Fundaciò Puigvert
Barcelona, Spain
Hospital Universitario Ramón y Cajal, University of Alcalá
Madrid, Spain
Bristol Urological Institute
Bristol, United Kingdom
Guy's Hospital
London, United Kingdom