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active surveillance for Renal Cyst (SOCRATIC Trial)

N/A
Recruiting
Led By Patrick O Richard, MD,MSc,FRCSC
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up
Awards & highlights

Summary

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.

Eligible Conditions
  • Renal Cyst

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
5-year cancer-specific survival
Secondary study objectives
2-year cancer-specific survival
2-year overall survival
5-year overall survival
+11 more
Other study objectives
Radiomic

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active surveillance
2015
N/A
~850
Surgery
2000
Completed Phase 3
~2490

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
302 Previous Clinical Trials
69,933 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,518,912 Total Patients Enrolled
Patrick O Richard, MD,MSc,FRCSCPrincipal InvestigatorUniversité de Sherbrooke
~196 spots leftby Dec 2029