Surveillance of Complex Renal Cysts - The SOCRATIC Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversité de Sherbrooke

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Active surveillance
  • Surgery

Treatment groups

330 Participants
are divided into 2 treatment groups

Sponsors and collaborators