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Surveillance of Complex Renal Cysts - The SOCRATIC Study
Sponsor: Université de Sherbrooke
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
330
Start Date
2021-02-02
Completion Date
2031-09-20
Last Updated
2025-06-22
Healthy Volunteers
No
Conditions
Interventions
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
Locations (18)
Prostate Cancer Center
Calgary, Alberta, Canada
Northern Alberta Urology Center
Edmonton, Alberta, Canada
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
Mens Health Clinic
Winnipeg, Manitoba, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
St-Joseph's Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Thunder Bay Health Sciences Center
Thunder Bay, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Woodstock hospital
Woodstock, Ontario, Canada
Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis
Lévis, Quebec, Canada
CHUM
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
CIUSSS Mauricie-Centre-du-Québec
Trois-Rivières, Quebec, Canada
CHU Bordeaux (URO-CCR)
Bordeaux, France