Actively Recruiting
Surveillance of Complex Renal Cysts The SOCRATIC Study
Led by Université de Sherbrooke · Updated on 2026-06-01
330
Participants Needed
18
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying complex renal cysts, specifically Bosniak III and IV cysts, which are common among individuals aged over 60 years. These cysts are traditionally treated with surgery due to concerns about malignancy, but recent evidence suggests many may be benign or have low risk of spreading. This observational study aims to compare long-term cancer-specific survival over five years between patients managed with active surveillance and those who undergo surgery, to better understand which approach is safer and more effective. Participants will choose either active surveillance or surgery as their management strategy. The active surveillance group will be closely monitored with abdominal imaging (ultrasound, CT, or MRI), chest X-rays or CT scans, and blood tests every six months for the first three years and annually thereafter. The surgery group will receive treatment as per standard care, which may include partial or total kidney resection or thermoablation. Both groups will be followed for up to five years to assess outcomes. During the study, participants will have regular research visits to assess their vital status and quality of life using validated questionnaires. Those under active surveillance will be monitored for cyst progression and may receive further therapy if needed. Researchers will measure cancer-specific survival, overall survival, tumor progression, quality of life changes, anxiety, and healthcare costs. The study will last up to five years, providing a comprehensive evaluation of these two management options.
CONDITIONS
Brief 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)
- Cyst size of 7 cm or less
- Cyst wall/septum nodule less than 10 mm or nodular/solid component 2 cm or smaller
- Estimated life expectancy greater than 5 years
- New diagnosis within 12 months from 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 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 prior to enrollment
- Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or recent heart issues within 6 months
- Evidence of metastatic disease or vascular/nodal disease
- Unwillingness to undergo monitoring and imaging studies
- Contraindications to contrast-enhanced imaging (eGFR less than 30 mL/min)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who opt for active surveillance will have close monitoring of their renal cysts through imaging and blood tests to track cyst progression and overall health status.
Semi-annual visits for the first 3 years, then annual visits thereafter
Duration - Treatment and standard care as determined by physician
Participants who opt for surgery will undergo partial or full kidney resection or thermoablation as decided by their physician, followed by annual imaging assessments.
1 surgery visit and annual imaging visits
Duration - Up to 5 years
Participants are followed for up to 5 years to monitor survival, disease progression, quality of life, and health costs regardless of management strategy.
Annual visits for follow-up assessments
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
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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