Surveillance of Complex Renal Cysts - The SOCRATIC Study
SOCRATIC
1 other identifier
observational
330
2 countries
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 22, 2020
CompletedStudy Start
First participant enrolled
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 20, 2031
June 22, 2025
January 1, 2025
8.9 years
August 31, 2020
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
5-year cancer-specific survival
Defined as kidney cancer survival 5 years after the enrollment
from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
Secondary Outcomes (14)
5-year overall survival
from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
2-year overall survival
from the date of enrollment (defined by signed consent) up to 2 years of follow-up
2-year cancer-specific survival
from the date of enrollment (defined by signed consent) up to 2 years of follow-up
Treatment-free survival
from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up
Discontinuation rate
from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
- +9 more secondary outcomes
Other Outcomes (1)
Radiomic
On diagnostic imaging, up to 12 months prior consent form
Study Arms (2)
active surveillance
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
surgery
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.
Interventions
Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)
Per standard of care: partial or full resection of the kidney, imaging annually
Eligibility Criteria
Patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Prostate Cancer Center
Calgary, Alberta, T2V 1P9, Canada
Northern Alberta Urology Center
Edmonton, Alberta, T6G 1Z1, Canada
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
Mens Health Clinic
Winnipeg, Manitoba, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
St-Joseph's Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Thunder Bay Health Sciences Center
Thunder Bay, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Woodstock hospital
Woodstock, Ontario, Canada
Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3Z1, Canada
CHUM
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
CIUSSS Mauricie-Centre-du-Québec
Trois-Rivières, Quebec, Canada
CHU Bordeaux (URO-CCR)
Bordeaux, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick O Richard, MD,MSc,FRCSC
Université de Sherbrooke
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 22, 2020
Study Start
February 2, 2021
Primary Completion (Estimated)
December 20, 2029
Study Completion (Estimated)
September 20, 2031
Last Updated
June 22, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share