International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)

Status: Recruiting
Location: See all (37) locations...
Intervention Type: Procedure, Diagnostic test
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.

• Age ≥18 years

• Informed consent signed

Locations
United States
California
Institute of Urology, University of Southern California.
RECRUITING
Los Angeles
University of California San Diego, Moores Cancer Center
RECRUITING
San Diego
Stanford University
NOT_YET_RECRUITING
Stanford
Illinois
Loyola University Medical Center, Edward Hines VA Hospital
NOT_YET_RECRUITING
Chicago
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Virginia
VCU Health System
RECRUITING
Richmond
Washington
Swedish Hospital
NOT_YET_RECRUITING
Seattle
Other Locations
Austria
Medical University of Vienna, Vienna General Hospital
RECRUITING
Vienna
Belgium
University of Bruxelles
RECRUITING
Brussels
Onze Lieve Vrouw Hospital
RECRUITING
Leuven
University Hospitals Leuven
NOT_YET_RECRUITING
Leuven
Brazil
Santa Casa da Misericórdia de Fortaleza
RECRUITING
Fortaleza
Greece
University of Patras
RECRUITING
Pátrai
Italy
Urology, Andrology & Kidney Transplantation Unit, University of Bari
RECRUITING
Bari
Policlinico S. Orsola Malpighi
RECRUITING
Bologna
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital
RECRUITING
Florence
Policlinico Riuniti, Università di Foggia.
RECRUITING
Foggia
Division of Urology, University of Genoa,Policlinico San Martino Hospital
RECRUITING
Genova
Azienda Ospedaliera Policlinico G. Martino, Università di Messina.
RECRUITING
Messina
Policlinico Istituto Europeo di Oncologia (IEO)
RECRUITING
Milan
San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital
RECRUITING
Milan
Istituto Nazionale dei Tumori Fondazione Senatore G. Pascale
RECRUITING
Napoli
Institute Oncology Veneto (IOV)
RECRUITING
Padua
Humanitas Hospital
RECRUITING
Rozzano
Università degli studi di Torino, Ospedale Molinette
RECRUITING
Torino
Università degli Studi di Torino, Ospedale S. Luigi Gonzaga.
RECRUITING
Torino
AOUI Verona
RECRUITING
Verona
Japan
Jikei University School of Medicine
NOT_YET_RECRUITING
Tokyo
Netherlands
Amsterdam University Medical Centers
RECRUITING
Amsterdam
Poland
European Health Center
RECRUITING
Otwock
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
RECRUITING
Warsaw
Russian Federation
N.N. Blokhin National Medical Research Center of Oncology
RECRUITING
Moscow
Singapore
NG Teng Fong General Hospital
RECRUITING
Singapore
Spain
Fundaciò Puigvert
RECRUITING
Barcelona
Hospital Universitario Ramón y Cajal, University of Alcalá
RECRUITING
Madrid
United Kingdom
Bristol Urological Institute
RECRUITING
Bristol
Guy's Hospital
RECRUITING
London
Contact Information
Primary
Marco Carini, Prof.
carini@unifi.it
055 794 6351
Backup
Andrea Minervini, Prof.
andrea.minervini@unifi.it
055 794 6351
Time Frame
Start Date: 2022-01-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 10000
Treatments
Renal tumor patiens
Patients with any renal tumor diagnosed with conventional imaging (computed tomography or magnetic resonance imaging) and undergoing to a clinical management in a hugh-volume center.
Related Therapeutic Areas
Sponsors
Collaborators: Italian Group for Advanced Laparo-Endoscopic and Robotic Urologic Surgery (AGILE), Società Italiana di Urologia (SIU)
Leads: Azienda Ospedaliero-Universitaria Careggi

This content was sourced from clinicaltrials.gov