Actively Recruiting
Surveillance of Complex Renal Cysts - The SOCRATIC Study
Led by Université de Sherbrooke · Updated on 2025-06-22
330
Participants Needed
18
Research Sites
554 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surveillance of Complex Renal Cysts - The SOCRATIC Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old and older
- Diagnosed with a Bosniak III or IV cyst (classification 2019)
- Cystic component size 7 cm or smaller
- Cyst wall/septum nodule less than 10 mm or nodular/solid component 2 cm or smaller in any axis
- Life expectancy greater than 5 years as estimated by a physician
- Diagnosis made within 12 months before study enrollment
- Currently asymptomatic from the disease
- Deemed fit enough for surgery
- Willing and able to complete questionnaires in French or English
- Able and willing to provide informed consent
You will not qualify if you...
- History of a hereditary renal cancer syndrome
- Presence of polycystic kidney disease
- Any prior history of renal cell carcinoma
- Received systemic therapy for another cancer within 12 months before enrollment
- Uncontrolled medical illnesses such as infections, hypertension, arrhythmias, heart failure, or recent heart attack/unstable angina within 6 months
- Metastatic disease or evidence of vascular or lymph node involvement
- Unwillingness to undergo monitoring and imaging studies
- Contraindication to contrast-enhanced imaging (estimated glomerular filtration rate less than 30 mL/min)
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Prostate Cancer Center
Calgary, Alberta, Canada, T2V 1P9
Actively Recruiting
2
Northern Alberta Urology Center
Edmonton, Alberta, Canada, T6G 1Z1
Actively Recruiting
3
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
Actively Recruiting
4
Mens Health Clinic
Winnipeg, Manitoba, Canada
Actively Recruiting
5
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Actively Recruiting
6
St-Joseph's Hospital
Hamilton, Ontario, Canada
Actively Recruiting
7
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
8
Thunder Bay Health Sciences Center
Thunder Bay, Ontario, Canada
Actively Recruiting
9
Princess Margaret Hospital
Toronto, Ontario, Canada
Actively Recruiting
10
Woodstock hospital
Woodstock, Ontario, Canada
Actively Recruiting
11
Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis
Lévis, Quebec, Canada, G6V 3Z1
Actively Recruiting
12
CHUM
Montreal, Quebec, Canada
Actively Recruiting
13
Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)
Montreal, Quebec, Canada
Actively Recruiting
14
McGill University Health Centre
Montreal, Quebec, Canada
Actively Recruiting
15
CHU de Québec - Université Laval
Québec, Quebec, Canada
Actively Recruiting
16
Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
17
CIUSSS Mauricie-Centre-du-Québec
Trois-Rivières, Quebec, Canada
Actively Recruiting
18
CHU Bordeaux (URO-CCR)
Bordeaux, France
Actively Recruiting
Research Team
A
Amelie Tetu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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