Surveillance of Complex Renal Cysts - The SOCRATIC Study
Université de Sherbrooke
330 participants
Feb 2, 2021
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- years old and older;
- diagnosed with a Bosniak III or IV cyst (classification 2019);
- size of cystic component ≤7cm;
- cyst wall/septum nodule (obtuse margin of protrusion) \<10mm (perpendicular axis) or nodular/solid component ≤2 cm in any axis;
- life expectancy \>5 years (by physician's estimate);
- new diagnosis ≤ 12 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 Criteria8
- history of a hereditary renal cancer syndrome;
- presence of polycystic kidney disease;
- any prior history of RCC;
- received systemic therapy for another malignancy within the 12 months prior to accrual;
- 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)
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Interventions
Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)
Per standard of care: partial or full resection of the kidney, imaging annually
Locations(18)
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NCT04558593