International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors

Conditions

• Kidney Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Partial Nephrectomy (PN) — PROCEDURE
  Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.
• 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.
• 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.
• 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.

Study Details

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).

Key Dates

Start date

Jan 10, 2022

Status verified

May 2022

Primary completion

Dec 31, 2023

Completion

Dec 31, 2028

Study Design

Enrollment

10,000 participants (estimated)

Arms

• Arm: 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.

Primary Outcome 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? [ Time Frame: Assesments of the outcome at 60 months from the surgical intervention. Time frame : 5 years ]

Central Contacts

• Marco Carini, Prof.
  055 794 6351
  [email protected]
• Andrea Minervini, Prof.
  055 794 6351
  [email protected]

Locations (7)

Find similar trials in Los Angeles, CA

Related Studies

• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado
• Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients
  Recruiting · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland
• A Study of VET3-TGI in Patients With Solid Tumors
  PHASE1 · Recruiting · KaliVir Immunotherapeutics · Los Angeles, California
• A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
  PHASE1/PHASE2 · Recruiting · A2 Biotherapeutics Inc. · Gilbert, Arizona