Actively Recruiting
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
Led by Azienda Ospedaliero-Universitaria Careggi · Updated on 2022-05-06
10000
Participants Needed
37
Research Sites
363 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero-Universitaria Careggi
Lead Sponsor
S
Società Italiana di Urologia (SIU)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
- Age �318 years
- Informed consent signed
You will not qualify if you...
- Patient refuses to participate in clinical research.
- Urothelial renal carcinoma.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Institute of Urology, University of Southern California.
Los Angeles, California, United States, 90007
Actively Recruiting
2
University of California San Diego, Moores Cancer Center
San Diego, California, United States, 92037
Actively Recruiting
3
Stanford University
Stanford, California, United States, 94304
Not Yet Recruiting
4
Loyola University Medical Center, Edward Hines VA Hospital
Chicago, Illinois, United States, 60141
Not Yet Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
6
VCU Health System
Richmond, Virginia, United States, 23298
Actively Recruiting
7
Swedish Hospital
Seattle, Washington, United States, 98122
Not Yet Recruiting
8
Medical University of Vienna, Vienna General Hospital
Vienna, Austria, 1090
Actively Recruiting
9
University of Bruxelles
Brussels, Belgium, 1050
Actively Recruiting
10
University Hospitals Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
11
Onze Lieve Vrouw Hospital
Leuven, Belgium, 8500
Actively Recruiting
12
Santa Casa da Misericórdia de Fortaleza
Fortaleza, Brazil, 60025
Actively Recruiting
13
University of Patras
Pátrai, Greece, 265 04
Actively Recruiting
14
Urology, Andrology & Kidney Transplantation Unit, University of Bari
Bari, Italy, 70121
Actively Recruiting
15
Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
Actively Recruiting
16
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital
Florence, Italy, 50100
Actively Recruiting
17
Policlinico Riuniti, Università di Foggia.
Foggia, Italy, 71122
Actively Recruiting
18
Division of Urology, University of Genoa,Policlinico San Martino Hospital
Genova, Italy, 16132
Actively Recruiting
19
Azienda Ospedaliera Policlinico "G. Martino", Università di Messina.
Messina, Italy, 98124
Actively Recruiting
20
San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital
Milan, Italy, 20132
Actively Recruiting
21
Policlinico Istituto Europeo di Oncologia (IEO)
Milan, Italy, 20141
Actively Recruiting
22
Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale"
Naples, Italy, 80131
Actively Recruiting
23
Institute Oncology Veneto (IOV)
Padova, Italy, 35128
Actively Recruiting
24
Humanitas Hospital
Rozzano, Italy, 20089
Actively Recruiting
25
Università degli Studi di Torino, Ospedale S. Luigi Gonzaga.
Torino, Italy, 10043
Actively Recruiting
26
Università degli studi di Torino, Ospedale Molinette
Torino, Italy, 10126
Actively Recruiting
27
AOUI Verona
Verona, Italy, 37126
Actively Recruiting
28
Jikei University School of Medicine
Tokyo, Japan, 105-8461
Not Yet Recruiting
29
Amsterdam University Medical Centers
Amsterdam, Netherlands, 1118
Actively Recruiting
30
European Health Center
Otwock, Poland, 05-400
Actively Recruiting
31
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Warsaw, Poland, 00-001
Actively Recruiting
32
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia, 119571
Actively Recruiting
33
NG Teng Fong General Hospital
Singapore, Singapore, 6090606
Actively Recruiting
34
Fundaciò Puigvert
Barcelona, Spain, 08025
Actively Recruiting
35
Hospital Universitario Ramón y Cajal, University of Alcalá
Madrid, Spain, 28034
Actively Recruiting
36
Bristol Urological Institute
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
37
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
M
Marco Carini, Prof.
CONTACT
A
Andrea Minervini, Prof.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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