Long-Term Study Comparing Surgery and Active Monitoring for Complex Renal Cysts Bosniak III and IV in Adults

What this Trial Is About

Researchers are studying complex renal cysts, specifically Bosniak III and IV cysts, which are common among individuals aged over 60 years. These cysts are traditionally treated with surgery due to concerns about malignancy, but recent evidence suggests many may be benign or have low risk of spreading. This observational study aims to compare long-term cancer-specific survival over five years between patients managed with active surveillance and those who undergo surgery, to better understand which approach is safer and more effective. Participants will choose either active surveillance or surgery as their management strategy. The active surveillance group will be closely monitored with abdominal imaging ultrasound, CT, or MRI, chest X-rays or CT scans, and blood tests every six months for the first three years and annually thereafter. The surgery group will receive treatment as per standard care, which may include partial or total kidney resection or thermoablation. Both groups will be followed for up to five years to assess outcomes. During the study, participants will have regular research visits to assess their vital status and quality of life using validated questionnaires. Those under active surveillance will be monitored for cyst progression and may receive further therapy if needed. Researchers will measure cancer-specific survival, overall survival, tumor progression, quality of life changes, anxiety, and healthcare costs. The study will last up to five years, providing a comprehensive evaluation of these two management options.

Surveillance of Complex Renal Cysts - The SOCRATIC Study