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Active surveillance is close monitoring (every 6 months the first 3 years following diagnosis and annually the following years), done per standard of care Close monitoring include: abdominal imaging (ultrasound, CT or MRI), chest X-ray or CT scan and blood tests",[13],"Procedure: Active surveillance",{"label":15,"type":10,"description":16,"interventionNames":17},"surgery","110 participants will be included in the surgery group. Surgery is done per standard of care. The type of surgery is at the discretion of the treating physician and may include: partial resection, total resection, thermoablation.",[18],"Procedure: Surgery",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Active surveillance","Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Surgery","Per standard of care: partial or full resection of the kidney, imaging annually",[15],[30],{"name":31,"affiliation":5,"role":32},"Patrick O Richard, MD,MSc,FRCSC","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Amelie 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Couture",{"facility":273,"status":43,"city":274,"state":10,"zip":10,"country":275,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"CHU Bordeaux (URO-CCR)","Bordeaux","France",{"type":49,"coordinates":277},[278,279],-0.58046,44.84124,{"lat":279,"lon":278},[282,284],{"name":283,"role":36,"phone":10,"phoneExt":10,"email":10},"Solène Ricard",{"name":285,"role":32,"phone":10,"phoneExt":10,"email":10},"Jean-Christophe Bernhard, MD",{"type":287,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100405378",false,"NCT04558593","Surveillance of Complex Renal Cysts - The SOCRATIC Study","SOCRATIC","Inclusion Criteria:\n\n* 18 years old and older;\n* diagnosed with a Bosniak III or IV cyst (classification 2019);\n* size of cystic component ≤7cm;\n* cyst wall\u002Fseptum nodule (obtuse margin of protrusion) \\\u003C10mm (perpendicular axis) or nodular\u002Fsolid component ≤2 cm in any axis;\n* life expectancy \\>5 years (by physician's estimate);\n* new diagnosis ≤ 12 months from accrual date;\n* currently asymptomatic from the disease;\n* deemed fit enough for surgery;\n* willingness and ability to complete questionnaires in either French or English;\n* able and willing to provide informed consent\n\nExclusion Criteria:\n\n* history of a hereditary renal cancer syndrome;\n* presence of polycystic kidney disease;\n* any prior history of RCC;\n* received systemic therapy for another malignancy within the 12 months prior to accrual;\n* uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction\u002Funstable angina within 6 months that would predispose to immediate surgical therapy;\n* metastatic disease or evidence of vascular or nodal disease;\n* unwillingness to undergo monitoring and imaging studies;\n* any contra-indication(s) to contrast-enhanced imaging (estimated glomerular filtration rate \\\u003C30min\u002FmL)","ALL","18 Years",{"count":297,"type":298},330,"ESTIMATED","OBSERVATIONAL","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\u002FIV cysts.\n\nThis 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.",[302],"Complex Renal Cyst",[304,305,306,307,308,9,309,15],"renal cyst","complex cyst","Bosniak III","Bosniak IV","renal masses","monitoring","2026-05-27",{"date":312,"type":313},"2026-06-01","ACTUAL",{"date":315,"type":313},"2021-02-02",{"date":317,"type":298},"2031-09-20",{"name":5,"class":6},18]