Monitoring small kidney tumors without immediate treatment
Sorveglianza Attiva Dei Tumori Renali T1a Uguali o Inferiori a 2 cm
This study is testing whether closely monitoring small kidney tumors in people over 50 can be a safe alternative to immediate surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT03804320 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic individuals over 50 years old with a single solid renal mass less than 2 cm.
Not a fit: Patients with a history of renal neoplasia, metastatic disease, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary surgeries and associated complications for patients with small kidney tumors.
How similar studies have performed: Previous studies on active surveillance for small renal masses have shown promising results, indicating that this approach may be viable for select patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Roberto Bertini — IRCCS San Raffaele
- Study coordinator: Cristina Carenzi
- Email: carenzi.cristina@hsr.it
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.