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Monitoring complex renal cysts to compare surgery and active surveillance

Surveillance of Complex Renal Cysts - The SOCRATIC Study

Observational Université de Sherbrooke · NCT04558593

This study is testing whether watching and monitoring complex kidney cysts is as safe and effective as surgery for patients with certain types of cysts.

Quick facts

Study typeObservational
Enrollment330 (estimated)
Ages18 Years and up
SexAll
SponsorUniversité de Sherbrooke Academic / other
Locations18 sites (Calgary, Alberta and 17 other locations)
Trial IDNCT04558593 on ClinicalTrials.gov

What this trial studies

This multicenter observational study aims to evaluate the long-term outcomes of active surveillance versus surgical intervention for patients diagnosed with Bosniak III and IV renal cysts. The study will follow patients over a five-year period to compare cancer-specific survival rates, disease progression, and overall patient well-being between the two management strategies. Participants will choose their management approach and will be monitored through standard care visits. The study seeks to provide evidence on the safety and efficacy of active surveillance as an alternative to surgery for these complex cysts.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed Bosniak III or IV cysts who are asymptomatic and have a life expectancy of more than five years.

Not a fit: Patients with a history of hereditary renal cancer syndromes or those with uncontrolled medical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could reduce unnecessary surgeries and associated complications for patients with benign renal cysts.

How similar studies have performed: Previous studies have suggested that active surveillance may be a viable option for managing complex renal cysts, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 18 years old and older;
* diagnosed with a Bosniak III or IV cyst (classification 2019);
* size of cystic component ≤7cm;
* cyst wall/septum nodule (obtuse margin of protrusion) \<10mm (perpendicular axis) or nodular/solid component ≤2 cm in any axis;
* life expectancy \>5 years (by physician's estimate);
* new diagnosis ≤ 12 months from accrual date;
* currently asymptomatic from the disease;
* deemed fit enough for surgery;
* willingness and ability to complete questionnaires in either French or English;
* able and willing to provide informed consent

Exclusion Criteria:

* history of a hereditary renal cancer syndrome;
* presence of polycystic kidney disease;
* any prior history of RCC;
* received systemic therapy for another malignancy within the 12 months prior to accrual;
* uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction/unstable angina within 6 months that would predispose to immediate surgical therapy;
* metastatic disease or evidence of vascular or nodal disease;
* unwillingness to undergo monitoring and imaging studies;
* any contra-indication(s) to contrast-enhanced imaging (estimated glomerular filtration rate \<30min/mL)

Where this trial is running

Calgary, Alberta and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Complex Renal Cystrenal cystcomplex cystBosniak IIIBosniak IVrenal massesactive surveillancemonitoring
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.