International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)

May 2, 2022 updated by: Andrea Minervini, Azienda Ospedaliero-Universitaria Careggi

International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marco Carini, Prof.
  • Phone Number: 055 794 6351
  • Email: carini@unifi.it

Study Contact Backup

Study Locations

  • Austria
  • Belgium
  • Brazil
      • Fortaleza, Brazil, 60025
        • Recruiting
        • Santa Casa da Misericórdia de Fortaleza
        • Contact:
  • Greece
      • Patras, Greece, 265 04
  • Italy
      • Bari, Italy, 70121
        • Recruiting
        • Urology, Andrology & Kidney Transplantation Unit, University of Bari
        • Contact:
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico S. Orsola Malpighi
        • Contact:
      • Firenze, Italy, 50100
        • Recruiting
        • Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital
        • Contact:
      • Foggia, Italy, 71122
      • Genova, Italy, 16132
        • Recruiting
        • Division of Urology, University of Genoa,Policlinico San Martino Hospital
        • Contact:
      • Messina, Italy, 98124
        • Recruiting
        • Azienda Ospedaliera Policlinico "G. Martino", Università di Messina.
        • Contact:
      • Milano, Italy, 20132
        • Recruiting
        • San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital
        • Contact:
      • Milano, Italy, 20141
        • Recruiting
        • Policlinico Istituto Europeo di Oncologia (IEO)
        • Contact:
      • Napoli, Italy, 80131
      • Padova, Italy, 35128
      • Rozzano, Italy, 20089
      • Torino, Italy, 10043
        • Recruiting
        • Università degli Studi di Torino, Ospedale S. Luigi Gonzaga.
        • Contact:
      • Torino, Italy, 10126
        • Recruiting
        • Università degli studi di Torino, Ospedale Molinette
        • Contact:
      • Verona, Italy, 37126
  • Japan
      • Tokyo, Japan, 105-8461
        • Not yet recruiting
        • Jikei University School of Medicine
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1118
        • Recruiting
        • Amsterdam University Medical Centers
        • Contact:
  • Poland
      • Otwock, Poland, 05-400
      • Warsaw, Poland, 00-001
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
        • Contact:
  • Russian Federation
      • Moscow, Russian Federation, 119571
        • Recruiting
        • N.N. Blokhin National Medical Research Center of Oncology
        • Contact:
  • Singapore
      • Singapore, Singapore, 6090606
  • Spain
  • United Kingdom
  • United States
    • California
      • Los Angeles, California, United States, 90007
      • San Diego, California, United States, 92037
        • Recruiting
        • University of California San Diego, Moores Cancer Center
        • Contact:
      • Stanford, California, United States, 94304
    • Illinois
      • Chicago, Illinois, United States, 60141
        • Not yet recruiting
        • Loyola University Medical Center, Edward Hines VA Hospital
        • Contact:
    • Pennsylvania
    • Virginia
      • Richmond, Virginia, United States, 23298
    • Washington
      • Seattle, Washington, United States, 98122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
Procedure: 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.
Procedure: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
Time Frame: Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years

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

"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 Outcome Measures

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

The following variables will be evaluated:

  1. Anthropometric, pre-operative and comorbidity data (patient characteristics).
  2. Imaging data and pre-operative tumor features (tumor characteristics).
  3. Centre facilities (laparoscopic/robot assisted, interventional radiology) , volume centre (PN/RN ratio, availability of Multidisciplinary Tumor Board)
  4. Intra-operative and post-operative data (treatment characteristics).
  5. Histopathological analysis (tumor histopathological characteristics). The outcome will be considered as the type of clinical management selected: active surveillance (AS) vs ablative treatment (AT) vs partial nephrectomy (PN) vs radical nephrectomy (RN).
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.
Time Frame: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months

The eventual anticoagulant therapy (heparin, warfarin, enoxaparin, fondaparinux) and/or antiplatelet therapy (clopidogrel, ticagrelor, prasugrel, dipyridamole, dipyridamole/aspirin, ticlopidine, eptifibatide) use in patients at baseline and at time of surgery will be assessed.

Hemorrhagic complications (graded according to the "Clavien-Dindo classification") will be evaluated during surgery (intraoperative) and within 90 days (postoperative) with particular attention to the management of hemorrhage (patient monitoring, transfusion, selective embolization, re-intervention with/without kidney removal).
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.
Time Frame: Outcome assesment will be done at 90 days from surgery. Time frame: 3 months

The eventual anticoagulant therapy (heparin, warfarin, NAO, enoxaparin, fondaparinux) and/or antiplatelet therapy (clopidogrel, ticagrelor, prasugrel, dipyridamole, dipyridamole/aspirin, ticlopidine, eptifibatide) use in patients at baseline and at time of surgery will be assessed.

Change of treatment from baseline to time of surgery will be considered and specifically evaluated according to the underlying cardio- and/or peripheral- and/or cerebro-vascular diseases.
Outcome assesment will be done at 90 days from surgery. Time frame: 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Collaborators

Società Italiana di Urologia (SIU)
Italian Group for Advanced Laparo-Endoscopic and Robotic Urologic Surgery (AGILE)

Investigators

  • Principal Investigator: Andrea Minervini, Prof., Dipartimento di Medicina Clinica e Sperimentale Via o Piazza Largo Brambilla 3 - 50134 Firenze (Italy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2028

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (ACTUAL)

May 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • i-RECORd

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol has been shared on the web platform of the i-RECORd project. The study has been shared with a specific Twitter page for the study.

IPD Sharing Time Frame

The data will be available after Clinical.trial.gov study acceptance

IPD Sharing Access Criteria

Access to the study protocol will be free to any researcher.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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