Status:
COMPLETED
Surveillance of Complex Renal Cysts - the SOCRATIC Pilot Study
Lead Sponsor:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborating Sponsors:
Canadian Urological Association
Kidney Cancer Canada
Conditions:
Renal Cyst
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
STUDY DESIGN - This is a two-arm multicenter prospective observational pilot study where patients with Bosniak III or IV choosing either active surveillance or surgery will be monitored closely. OBJEC...
Eligibility Criteria
Inclusion
- aged ≥18 years at the time of diagnosis
- diagnosed with a Bosniak III or IV cyst
- size of cystic component ≤7cm
- solid component ≤2 cm in maximal diameter for Bosniak IV cysts
- life expectancy \>5 years (by physician's estimate)
- diagnosis ≤6 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.
Exclusion
- history of a hereditary renal cancer syndrome
- presence of polycystic kidney disease
- systemic therapy for another malignancy within 12 months of recruitment date
- 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)
Key Trial Info
Start Date :
September 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04079764
Start Date
September 30 2019
End Date
December 31 2022
Last Update
February 15 2024
Active Locations (3)
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1
St Joseph's Healthcare
Hamilton, Ontario, Canada
2
Princess Margaret Cancer Center
Toronto, Ontario, Canada
3
Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4