Surveillance of Complex Renal Cysts - The SOCRATIC Study

Launched by UNIVERSITÉ DE SHERBROOKE · Sep 15, 2020

Keywords

ClinConnect Summary

The SOCRATIC Study is a clinical trial that is looking at how to best manage complex kidney cysts, specifically those classified as Bosniak III and IV. These types of cysts are often found in older adults, and while surgery is a common treatment, it can come with significant risks and complications. This study aims to compare the safety and effectiveness of two approaches: active surveillance (monitoring the cyst over time without immediate surgery) versus surgical removal of the cyst. Researchers want to see how these two options affect cancer survival over five years.

To participate in this trial, individuals must be 18 years or older and have a new diagnosis of a Bosniak III or IV cyst that is smaller than 7 cm. They should not have any symptoms related to the cyst and must be healthy enough for surgery if needed. Participants will go through regular check-ups and imaging tests to monitor their condition, and they will be asked to fill out some questionnaires in either French or English. This study is currently recruiting participants and aims to provide important information about managing kidney cysts safely without unnecessary surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 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 Criteria:
• • 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)