~181 spots leftby Dec 2029

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

Palo Alto (17 mi)
Overseen byPatrick O Richard, MD,MSc,FRCSC
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
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.

Eligibility Criteria

Treatment Details

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

Find a clinic near you

Research locations nearbySelect from list below to view details:
CHUMMontreal, Canada
CHU de Québec - Université LavalQuébec, Canada
Centre de recherche du Centre hospitalier Universitaire de SherbrookeSherbrooke, Canada
The Ottawa HospitalOttawa, Canada
More Trial Locations
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Who is running the clinical trial?

Université de SherbrookeLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator

References