Careggi Hospital-University
Andrea Minervini
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).
Kidney Cancer
Partial Nephrectomy (PN)
Radical Nephrectomy (RN)
Ablation therapy (AT)
Active Surveillance (AS)
Study design 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.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 10000 participants |
| Official Title : | International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd) |
| Actual Study Start Date : | 2022-01-10 |
| Estimated Primary Completion Date : | 2023-12-31 |
| Estimated Study Completion Date : | 2028-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Institute of Urology, University of Southern California.
Los Angeles, California, United States, 90007
RECRUITING
University of California San Diego, Moores Cancer Center
San Diego, California, United States, 92037
NOT YET RECRUITING
Stanford University
Stanford, California, United States, 94304
NOT YET RECRUITING
Loyola University Medical Center, Edward Hines VA Hospital
Chicago, Illinois, United States, 60141
NOT YET RECRUITING
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
RECRUITING
VCU Health System
Richmond, Virginia, United States, 23298
NOT YET RECRUITING
Swedish Hospital
Seattle, Washington, United States, 98122
RECRUITING
Medical University of Vienna, Vienna General Hospital
Vienna, Austria, 1090
RECRUITING
University of Bruxelles
Bruxelles, Belgium, 1050
NOT YET RECRUITING
University Hospitals Leuven
Leuven, Belgium, 3000
RECRUITING
Our Lady Hospital
Leuven, Belgium, 8500
RECRUITING
Santa Casa da Misericórdia de Fortaleza
Fortaleza, Brazil, 60025
RECRUITING
University of Patras
Patras, Greece, 265 04
RECRUITING
Urology, Andrology & Kidney Transplantation Unit, University of Bari
Bari, Italy, 70121
RECRUITING
Polyclinic S. Orsola Malpighi
Bologna, Italy, 40138
RECRUITING
Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital
Firenze, Italy, 50100
RECRUITING
Policlinico Riuniti, University of Foggia.
Foggia, Italy, 71122
RECRUITING
Division of Urology, University of Genoa, Policlinico San Martino Hospital
Genova, Italy, 16132
RECRUITING
Polyclinic Hospital "G. Martino", University of Messina.
Messina, Italy, 98124
RECRUITING
San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital
Milano, Italy, 20132
RECRUITING
Polyclinic European Institute of Oncology (IEO)
Milano, Italy, 20141
RECRUITING
National Institute of Tumors Senator Foundation "G. Pascale"
Napoli, Italy, 80131
RECRUITING
Institute Oncology Veneto (IOV)
Padova, Italy, 35128
RECRUITING
Humanity Hospital
Rozzano, Italy, 20089
RECRUITING
University of Turin, S. Luigi Gonzaga Hospital.
Torino, Italy, 10043
RECRUITING
University of Turin, Molinette Hospital
Torino, Italy, 10126
RECRUITING
Aoui Verona
Verona, Italy, 37126
NOT YET RECRUITING
Jikei University School of Medicine
Tokyo, Japan, 105-8461
RECRUITING
Amsterdam University Medical Centers
Amsterdam, Netherlands, 1118
RECRUITING
European Health Center
Otwock, Poland, 05-400
RECRUITING
National Oncology Institute Maria Sklodowska-Curie
Warsaw, Poland, 00-001
RECRUITING
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russian Federation, 119571
RECRUITING
Of Teng Fong General Hospital
Singapore, Singapore, 6090606
RECRUITING
Fundaciò Puigvert
Barcelona, Spain, 08025
RECRUITING
Ramón y Cajal University Hospital, University of Alcalá
Madrid, Spain, 28034
RECRUITING
Bristol Urological Institute
Bristol, United Kingdom, BS10 5NB
RECRUITING
Guy's Hospital
London, United Kingdom, SE1 9RT