RecruitingNCT05363657

International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors

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


Sponsor

Azienda Ospedaliero-Universitaria Careggi

Enrollment

10,000 participants

Start Date

Jan 10, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
  • Age ≥18 years
  • Informed consent signed

Exclusion Criteria2

  • Patient refuse to participate in clinical research.
  • Urothelial renal carcinoma.

Interventions

PROCEDUREPartial Nephrectomy (PN)

Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.

PROCEDURERadical 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.

PROCEDUREAblation 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.

DIAGNOSTIC_TESTActive 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"

Napoli, Italy

Institute Oncology Veneto (IOV)

Padua, 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

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NCT05363657


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