Actively Recruiting

Age: 18Years +
All Genders
NCT05363657

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
  • Age �318 years
  • Informed consent signed
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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