Monitoring small kidney tumors without immediate treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on the active surveillance of small renal masses (SRMs) in asymptomatic patients over 50 years old. Participants diagnosed with a single solid renal mass of 2 cm or less will be monitored over a five-year period, with evaluations at regular intervals to assess tumor progression. The study aims to determine the safety and efficacy of this non-invasive approach compared to immediate surgical intervention. Follow-up will continue for up to ten years to track long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ability to read, understand and interpret an informed consent;
2. voluntary subscription of the active surveillance protocol through written informed consent; 3) age over 50 years;

4\) diagnosis of monolateral, monofocal, and first-rate solid renal mass less than 2 cm; 5) absence of symptoms due to renal tumor pathology.

Exclusion Criteria:

1. patients with a history of previous renal neoplasia;
2. monorenal patients;
3. patients with hereditary renal tumors (such as tuberous sclerosis and Von Hippel Lindau syndrome, etc.);
4. patients with metastasis;
5. patients suffering from immunodepressive diseases;
6. patients on concomitant therapy with chemotherapeutic agents or systemic immunosuppressants;
7. patients with life expectancy of less than 1 year.

Where it's running

• IRCCS San Raffaele
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Roberto Bertini — IRCCS San Raffaele
• Study coordinator: Cristina Carenzi
• Email: carenzi.cristina@hsr.it

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.