Surveillance of Complex Renal Cysts - the SOCRATIC Study
(SOCRATIC Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen byPatrick O Richard, MD,MSc,FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Université de Sherbrooke

No Placebo Group

Trial Summary

What is the purpose of 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.

Research Team

Patrick O Richard, MD,MSc,FRCSC

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

Inclusion Criteria

able and willing to provide informed consent

new diagnosis ≤ 12 months from accrual date;

currently asymptomatic from the disease;

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Treatment Details

Interventions

Active surveillance (Other)
Surgery (Surgery)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: surgeryExperimental Treatment1 Intervention

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.

Group II: active surveillanceExperimental Treatment1 Intervention

220 participants will be included in the active surveillance group. 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