Recruiting

Observational Study

Sponsor:

Azienda Ospedaliero-Universitaria Careggi

Code:

NCT05363657

Conditions

Kidney Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Partial Nephrectomy (PN)

Radical Nephrectomy (RN)

Ablation therapy (AT)

Active Surveillance (AS)

Study Details

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).

Conditions

Kidney Cancer

Study ID

NCT05363657

Start date

Jan 10, 2022

Status verified date

May, 2022

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 ]
  • 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. ]

Central Contacts and Locations

Central contacts

Locations

Institute of Urology, University of Southern California.

Recruiting

Los Angeles, California, United States, 90007

Contacts

Giovanni E Cacciamani

giovanni.cacciamani@med.usc.edu

University of California San Diego, Moores Cancer Center

Recruiting

San Diego, California, United States, 92037

Contacts

Ithaar Derweesh

iderweesh@gmail.com

VCU Health System

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Riccardo Autorino

ricautor@gmail.com

More Information

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Last update posted

May 6, 2022

Last verified

May, 2022

Keywords

  • Kidney cancer
  • Partial Nephrectomy
  • Radical Nephrectomy
  • Ablation Techniques
  • Active Surveillance
  • Recurrence Free Survival
  • Watchful Waiting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Azienda Ospedaliero-Universitaria Careggi on 2022-05-06.