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RECRUITING
NCT04558593

Surveillance of Complex Renal Cysts - The SOCRATIC Study

Sponsor: Université de Sherbrooke

View on ClinicalTrials.gov

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

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

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