Clinical trial NCT05363657: International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors
Official title: International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Cancer
Keywords: Kidney cancer
Partial Nephrectomy
Radical Nephrectomy
Ablation Techniques
Active Surveillance
Recurrence Free Survival
Watchful Waiting
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
Collaborators: name: Società Italiana di Urologia (SIU)
name: Italian Group for Advanced Laparo-Endoscopic and Robotic Urologic Surgery (AGILE)
First posted: 2022-05-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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?
timeFrame: Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years
measure: 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.
timeFrame: Assesment of the "Trifecta" outcome will be performed at 12 months from the surgical intervention. Time frame: 1 year.
Secondary outcomes:
measure: 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.
timeFrame: Assesment will be done at the time of registering the type of surgery/clinical managing adopted. Time frame: <1 week from patients accrual..
measure: To evaluate the impact of the antiaggregant and/or antiplatelet treatment at baseline and during partial nephrectomy on hemorrhagic complications.
timeFrame: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months
measure: 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.
timeFrame: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Institute of Urology, University of Southern California.
state: California
city: San Diego
country: United States
facility: University of California San Diego, Moores Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Loyola University Medical Center, Edward Hines VA Hospital
state: Illinois
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Richmond
country: United States
facility: VCU Health System
state: Virginia
city: Seattle
country: United States
facility: Swedish Hospital
state: Washington
city: Vienna
country: Austria
facility: Medical University of Vienna, Vienna General Hospital
city: Bruxelles
country: Belgium
facility: University of Bruxelles
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Leuven
country: Belgium
facility: Onze Lieve Vrouw Hospital
city: Fortaleza
country: Brazil
facility: Santa Casa da Misericórdia de Fortaleza
city: Patras
country: Greece
facility: University of Patras
city: Bari
country: Italy
facility: Urology, Andrology & Kidney Transplantation Unit, University of Bari
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Firenze
country: Italy
facility: Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital
city: Foggia
country: Italy
facility: Policlinico Riuniti, Università di Foggia.
city: Genova
country: Italy
facility: Division of Urology, University of Genoa,Policlinico San Martino Hospital
city: Messina
country: Italy
facility: Azienda Ospedaliera Policlinico "G. Martino", Università di Messina.
city: Milano
country: Italy
facility: San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital
city: Milano
country: Italy
facility: Policlinico Istituto Europeo di Oncologia (IEO)
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori Fondazione Senatore "G. Pascale"
city: Padova
country: Italy
facility: Institute Oncology Veneto (IOV)
city: Rozzano
country: Italy
facility: Humanitas Hospital
city: Torino
country: Italy
facility: Università degli Studi di Torino, Ospedale S. Luigi Gonzaga.
city: Torino
country: Italy
facility: Università degli studi di Torino, Ospedale Molinette
city: Verona
country: Italy
facility: AOUI Verona
city: Tokyo
country: Japan
facility: Jikei University School of Medicine
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
city: Otwock
country: Poland
facility: European Health Center
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
city: Moscow
country: Russian Federation
facility: N.N. Blokhin National Medical Research Center of Oncology
city: Singapore
country: Singapore
facility: NG Teng Fong General Hospital
city: Barcelona
country: Spain
facility: Fundaciò Puigvert
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal, University of Alcalá
city: Bristol
country: United Kingdom
facility: Bristol Urological Institute
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Dipartimento di Medicina Clinica e Sperimentale Via o Piazza Largo Brambilla 3 - 50134 Firenze (Italy)
name: Andrea Minervini, Prof.
role: PRINCIPAL_INVESTIGATOR
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