Surveillance of Complex Renal Cysts - The SOCRATIC Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Active surveillance: Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)

Surgery: Per standard of care: partial or full resection of the kidney, imaging annually

Study summary

One third of individuals aged \>60 years will be diagnosed with at least one renal cyst following abdominal imaging. These cystic lesions are categorized according to the Bosniak classification which categorizes cysts according to their degree of complexity and risk of malignancy. Growing evidence suggests that a significant proportion of Bosniak III and IV cysts are benign and that the malignant ones present low metastatic potential. Since renal surgery carries substantial morbidity (20%) and potential mortality (0.5%), active surveillance has gained attention as a potential tradeoff to surgery to overcome overtreatment. Therefore, prospective studies of long-term follow-up are needed to confirm the oncologic safety of this strategy for patients with Bosniak III/IV cysts.

This is an multicenter prospective observational longitudinal study. The main objective is to compare the 5-year follow-up cancer-specific survival between the active surveillance and the surgical groups.

Eligibility

Primary outcome measure(s)

• 5-year cancer-specific survival — from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
  Defined as kidney cancer survival 5 years after the enrollment

Trial sites (18)