RECRUITING

International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-01-10
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05363657

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
  2. * Age ≥18 years
  3. * Informed consent signed
  1. * Patient refuse to participate in clinical research.
  2. * Urothelial renal carcinoma.

Contacts and Locations

Study Contact

Marco Carini, Prof.
CONTACT
055 794 6351
carini@unifi.it
Andrea Minervini, Prof.
CONTACT
055 794 6351
andrea.minervini@unifi.it

Principal Investigator

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

Study Locations (Sites)

Institute of Urology, University of Southern California.
Los Angeles, California, 90007
United States
University of California San Diego, Moores Cancer Center
San Diego, California, 92037
United States
Stanford University
Stanford, California, 94304
United States
Loyola University Medical Center, Edward Hines VA Hospital
Chicago, Illinois, 60141
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
VCU Health System
Richmond, Virginia, 23298
United States
Swedish Hospital
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Azienda Ospedaliero-Universitaria Careggi

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

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 Registration Dates

Study Start Date2022-01-10
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2022-01-10
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Kidney Cancer