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Surveillance of Complex Renal Cysts - The SOCRATIC Study

Recruitingn/aAges 18 Years - anyAllUniversité de Sherbrooke
NCT04558593 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fo

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📋 Eligibility rules (as published)
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)
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What it tests

  • Active surveillance
  • Surgery
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Where

18 sites
Prostate Cancer Center
Calgary, Canada
Northern Alberta Urology Center
Edmonton, Canada
Vancouver Prostate Centre
Vancouver, Canada
Mens Health Clinic
Winnipeg, Canada
Nova Scotia Health Authority
Halifax, Canada
St-Joseph's Hospital
Hamilton, Canada
The Ottawa Hospital
Ottawa, Canada
Thunder Bay Health Sciences Center
Thunder Bay, Canada

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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