Surveillance of Complex Renal Cysts - The SOCRATIC Study
Recruiting now
Conditions studied: Complex Renal Cyst
In brief
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.
Key facts
- Study ID
- NCT04558593
- Run by
- Université de Sherbrooke
- People needed
- 330
- Starts
- 2021-02-02
- Expected to finish
- 2031-09-20
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Prostate Cancer Center — Calgary, Alberta, Canada (enrolling)
- Northern Alberta Urology Center — Edmonton, Alberta, Canada (enrolling)
- Vancouver Prostate Centre — Vancouver, British Columbia, Canada (enrolling)
- Mens Health Clinic — Winnipeg, Manitoba, Canada (enrolling)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (enrolling)
- St-Joseph's Hospital — Hamilton, Ontario, Canada (enrolling)
- The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
- Thunder Bay Health Sciences Center — Thunder Bay, Ontario, Canada (enrolling)
- Princess Margaret Hospital — Toronto, Ontario, Canada (enrolling)
- Woodstock hospital — Woodstock, Ontario, Canada (enrolling)
- Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis — Lévis, Quebec, Canada (enrolling)
- CHUM — Montreal, Quebec, Canada (enrolling)
- Hôpital Maisonneuve-Rosemont (CISSS-EIMtl) — Montreal, Quebec, Canada (enrolling)
- McGill University Health Centre — Montreal, Quebec, Canada (enrolling)
- CHU de Québec - Université Laval — Québec, Quebec, Canada (enrolling)
- Centre de recherche du Centre hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (enrolling)
- CIUSSS Mauricie-Centre-du-Québec — Trois-Rivières, Quebec, Canada (enrolling)
- CHU Bordeaux (URO-CCR) — Bordeaux, France (enrolling)
Full record on ClinicalTrials.gov
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