International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
NCT ID: NCT05363657
Last Updated: 2022-05-06
Study Results
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Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2022-01-10
2028-12-31
Brief Summary
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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).
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Detailed Description
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The overall objective of the i-RECORD project is to build a multicentre multi-arm multi-stage prospective observational registry collecting data on the management of kidney cancer in consecutive patients treated at 50 tertiary referral Centers worldwide over a 2 years-period and with 5 years of follow-up
. On this registry, six prospective trials with specific objectives have been built.
The i-RECORd project is designed as an observational prospective longitudinal trial involving 50 international, very-high-volume tertiary referral Centers with extensive experience in management of kidney cancer. Centers will be included in the project only if they will be able to certify at least to: 1) perform 150 partial and radical nephrectomy/year, or 2) to perform 80 ATs/year, or 3) to include 50 patients in WW/AS protocols/year.
The enrollment and follow-up periods will be 2 and 5 years, respectively. The estimate of patients' enrollment over the study period is 10'000 inclusions.
The 50 Centers finally enrolled in the i-RECORD project will be given the access to a web-based platform for data collection for 24 months from the starting date of the project.
A web-based e-form platform will be used for data collection.
Data collection
This observational study aims to obtain controlled, qualitative and quantitative, data of the enrolled patients through a web-based e-form platform. For all patients it will be asked to complete a data collection form specifically designed for this study, consisting of some subfolders:
1. Anthropometric, pre-operative and comorbidity data (patient characteristics).
2. Imaging data e and pre-operative tumor features (tumor characteristics).
3. Intra-operative and post-operative data (treatment characteristics).
4. Histopathological analysis (tumor histopathological characteristics).
5. Patients follow-up variables (at 6, 12, 24 and 60 months from the treatment) (follow-up characteristics).
Decision Analysis Modeling
Beyond traditional descriptive and inferential statistical analyses, the i-RECORd project will provide a comprehensive overview of the current selection criteria for each type of management option by applying innovative statistical methods (Decision Analysis Modeling through discrete choice models) to determine the differential impact of all potential relevant variables on the choice of treatment. To do so, we will consider specific clinical scenarios (clinical clusters) made of the integration of patient characteristics (comorbidity score, performance status, age, gender, etc.), patient-reported outcomes measures (PROMs), tumors anatomical features (degree of complexity, clinical diameter, side, location within the kidney, involvement of renal sinus or collecting system, etc.), surgeon-related factors (surgical experience and background), hospital economic availabilities (i.e. open, laparoscopic, robotic surgery) and other country-specific socio-economical features in order to determine the impact of such variables on the final choice of treatment.
By applying the discrete choice model to the analysis of the prospective dataset, the i-RECORd project will overcome the current state of the art in the treatment of localized renal tumors as it will show how the choice of treatment is performed by the decision-maker (at a surgeon- and hospital-level) in each specific clinical cluster of patients, why that choice was performed according to a careful analysis of the personalized patient setting and whether that choice will influence the postoperative outcomes.
Adapted MAMS Registry
The i-RECORD will be designed adapting the innovative concept of multi-arm, multi-stage (MAMS) platform randomized trials (used, for instance, for the design of the Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) Trial) to create a dynamic, observational registry evaluating simultaneously different management options in different patient- and/or tumor-related scenarios.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Partial Nephrectomy (PN)
Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Radical 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.
Ablation 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.
Active 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.
Interventions
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Partial Nephrectomy (PN)
Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Radical 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.
Ablation 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.
Active 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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Informed consent signed
Exclusion Criteria
* Urothelial renal carcinoma.
18 Years
ALL
No
Sponsors
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Società Italiana di Urologia (SIU)
OTHER
Italian Group for Advanced Laparo-Endoscopic and Robotic Urologic Surgery (AGILE)
UNKNOWN
Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Andrea Minervini
Professor
Principal Investigators
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Andrea Minervini, Prof.
Role: PRINCIPAL_INVESTIGATOR
Dipartimento di Medicina Clinica e Sperimentale Via o Piazza Largo Brambilla 3 - 50134 Firenze (Italy)
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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i-RECORd
Identifier Type: -
Identifier Source: org_study_id
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