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Surveillance of Complex Renal Cysts - The SOCRATIC Study

NCT04558593 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2026-06-01

No results posted yet for this 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.

Conditions

  • Complex Renal Cyst

Interventions

PROCEDURE

Active surveillance

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

PROCEDURE

Surgery

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

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Patrick O Richard, MD,MSc,FRCSC · Université de Sherbrooke

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2029-12-20
Completion
2031-09-20

Countries

  • Canada
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04558593 on ClinicalTrials.gov