International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors

NCT05363657 | Recruiting

• 1 other identifier: i-RECORd
• Study Type: observational
• Target: 10,000
• Locations: 13 countries
• Sites: 37

Brief 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).

Conditions

Kidney Cancer

Keywords

Kidney cancer; Partial Nephrectomy; Radical Nephrectomy; Ablation Techniques; Active Surveillance; Recurrence Free Survival; Watchful Waiting

Outcome Measures

Primary Outcomes (2)

• To test the effectiveness of partial nephrectomy for the treatment of localized renal tumors (T1-T2N0M0) with regards to recurrence-free survival and cardiovascular accidents and mortality in comparison to radical nephrectomy?

  The preoperative characteristics of the patients will be specifically evaluated to calculate any heterogeneity between the two groups. In detail, anthropometric and comorbidity features, previous abdominal surgery, blood chemistry values, blood pressure, smoking habit, preoperative life expectancy, and frailty grade will be assessed. Imaging features of the tumor will be considered, including the characteristics necessary for the calculation of the PADUA, R.E.N.A.L., and Contact-Surface-Area scores. Patients with a node-positive or metastatic disease diagnosed with conventional imaging (CT scan/MRI) will be excluded. Intra-operative and post-operative outcomes will be evaluated. Histopathological features of the tumor will be assessed. Patients will be followed up with conventional imaging according to the International guidelines (ultrasound, CT, MRI). Serum creatinine, platelets and estimated glomerular function (eGFR), the onset of cardiovascular adverse events will be registered.

  Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years

• To test the effectiveness of robotic approach in partial nephrectomy to increase the "Trifecta" rate after nephron-sparing surgery in patients with T1-T2N0M0 renal tumors.

  "Trifecta" rate is defined as 1) Absence of intraoperative and postoperative surgical complications; 2) absence of positive surgical margins or recurrences on tumor resection site during a 5-year follow-up; 3) Absence of clinically significant renal function loss at one year after surgery. Renal function will be evaluated using the estimated glomerular filtration rate (eGFR) in ml/min/1.73 m\^2 using the CKD-EPI Creatinine Equation (2021). A clinically significant loss will be considered if \>25% from eGFR at baseline. The "Trifecta" outcome will be evaluated one year from surgery.

  Assesment of the "Trifecta" outcome will be performed at 12 months from the surgical intervention. Time frame: 1 year.

Secondary Outcomes (3)

• To evaluate the differential impact of patients' comorbidities, tumors' complexity, surgeons' experience, country-related socio-cultural factors and hospital financial resources on the selection of the type of clinical management.

  Assesment will be done at the time of registering the type of surgery/clinical managing adopted. Time frame: <1 week from patients accrual..

• To evaluate the impact of the antiaggregant and/or antiplatelet treatment at baseline and during partial nephrectomy on hemorrhagic complications.

  Outcome assesment will be done at 90 days from surgery. Time frame: 3 months

• To assess in patients with antiaggregant and/or antiplatelet treatment at baseline any potential change of this therapy at the time of treatment associated with the absence of hemorrhagic complications.

  Outcome assesment will be done at 90 days from surgery. Time frame: 3 months

Study Arms (1)

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.

Procedure: Partial Nephrectomy (PN); Procedure: Radical Nephrectomy (RN); Procedure: Ablation therapy (AT); Diagnostic Test: Active Surveillance (AS)

Interventions

Partial Nephrectomy (PN) PROCEDURE

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

Renal tumor patiens

Radical Nephrectomy (RN) PROCEDURE

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.

Renal tumor patiens

Ablation therapy (AT) PROCEDURE

The procedure of tumor ablation performed with radiofrequency or cryoablation. The procedure can be performed either with a laparoscopic approach or percutaneous access.

Renal tumor patiens

Active Surveillance (AS) DIAGNOSTIC_TEST

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.

Renal tumor patiens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population include patients with a radiological diagnosis of kidney tumor susceptible to surgical treatment (RN or PN) or AT or WW/AS will be eligible.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead
• Società Italiana di Urologia (SIU): collaborator
• Italian Group for Advanced Laparo-Endoscopic and Robotic Urologic Surgery (AGILE): collaborator

Study Sites (37)

Institute of Urology, University of Southern California.

Los Angeles, California, 90007, United States

RECRUITING

University of California San Diego, Moores Cancer Center

San Diego, California, 92037, United States

RECRUITING

Stanford University

Stanford, California, 94304, United States

NOT YET RECRUITING

Loyola University Medical Center, Edward Hines VA Hospital

Chicago, Illinois, 60141, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

VCU Health System

Richmond, Virginia, 23298, United States

RECRUITING

Swedish Hospital

Seattle, Washington, 98122, United States

NOT YET RECRUITING

Medical University of Vienna, Vienna General Hospital

Vienna, 1090, Austria

RECRUITING

University of Bruxelles

Brussels, 1050, Belgium

RECRUITING

University Hospitals Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Onze Lieve Vrouw Hospital

Leuven, 8500, Belgium

RECRUITING

Santa Casa da Misericórdia de Fortaleza

Fortaleza, 60025, Brazil

RECRUITING

University of Patras

Pátrai, 265 04, Greece

RECRUITING

Urology, Andrology & Kidney Transplantation Unit, University of Bari

Bari, 70121, Italy

RECRUITING

Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

RECRUITING

Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital

Florence, 50100, Italy

RECRUITING

Policlinico Riuniti, Università di Foggia.

Foggia, 71122, Italy

RECRUITING

Division of Urology, University of Genoa,Policlinico San Martino Hospital

Genova, 16132, Italy

RECRUITING

Azienda Ospedaliera Policlinico "G. Martino", Università di Messina.

Messina, 98124, Italy

RECRUITING

San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

Policlinico Istituto Europeo di Oncologia (IEO)

Milan, 20141, Italy

RECRUITING

Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale"

Napoli, 80131, Italy

RECRUITING

Institute Oncology Veneto (IOV)

Padua, 35128, Italy

RECRUITING

Humanitas Hospital

Rozzano, 20089, Italy

RECRUITING

Università degli Studi di Torino, Ospedale S. Luigi Gonzaga.

Torino, 10043, Italy

RECRUITING

Università degli studi di Torino, Ospedale Molinette

Torino, 10126, Italy

RECRUITING

AOUI Verona

Verona, 37126, Italy

RECRUITING

Jikei University School of Medicine

Tokyo, 105-8461, Japan

NOT YET RECRUITING

Amsterdam University Medical Centers

Amsterdam, 1118, Netherlands

RECRUITING

European Health Center

Otwock, 05-400, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

Warsaw, 00-001, Poland

RECRUITING

N.N. Blokhin National Medical Research Center of Oncology

Moscow, 119571, Russia

RECRUITING

NG Teng Fong General Hospital

Singapore, 6090606, Singapore

RECRUITING

Fundaciò Puigvert

Barcelona, 08025, Spain

RECRUITING

Hospital Universitario Ramón y Cajal, University of Alcalá

Madrid, 28034, Spain

RECRUITING

Bristol Urological Institute

Bristol, BS10 5NB, United Kingdom

RECRUITING

Guy's Hospital

London, SE1 9RT, United Kingdom

RECRUITING

Related Publications (15)

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MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Andrea Minervini, Prof.

  Dipartimento di Medicina Clinica e Sperimentale Via o Piazza Largo Brambilla 3 - 50134 Firenze (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Carini, Prof.

CONTACT

055 794 6351; carini@unifi.it

Andrea Minervini, Prof.

CONTACT

055 794 6351; andrea.minervini@unifi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: May 6, 2022
• Study Start: January 10, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available after Clinical.trial.gov study acceptance
• Access Criteria: Access to the study protocol will be free to any researcher.

Locations

GR (1); BE (3); ES (2); BR (1); JP (1); PL (2); US (7); SG (1); RU (1); AU (1); IT (14); GB (2); NL (1)