Complex Renal CystSOCRATICNCT04558593
Surveillance of Complex Renal Cysts - The SOCRATIC Study
An observational study of Complex Renal Cyst, run by Université de Sherbrooke at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Renal Cyst
- What is being tested?
- Active surveillance and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 2 Feb 2021to 20 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance
Who may be able to join
- 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;
- life expectancy >5 years (by physician's estimate);
- new diagnosis ≤ 12 months from accrual date;
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
Canada17 sites, 17 recruiting
- Recruiting
Prostate Cancer Center
Calgary, Alberta, T2V 1P9
Lora Mendoza
Bimal Bhindi
- Recruiting
Northern Alberta Urology Center
Edmonton, Alberta, T6G 1Z1
Stacey Broomfield
Lucas Dean, MD
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia
Kelly MacDonald
Dani Clegg
- Recruiting
St-Joseph's Hospital
Hamilton, Ontario
Marie Therese Balart
Rahul Bansal, MD
- Recruiting
Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3Z1
Estel Duquet-Deblois
Matthieu Gratton
- Recruiting
CHUM
Montreal, Quebec
Amal Nadiri
Jean-Baptiste Lattouf
- Recruiting
Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)
Montreal, Quebec
Samara Bloom
Nawar Hanna, MD
- Recruiting
McGill University Health Centre
Montreal, Quebec
Rodrigo Skowronski
Simon Tanguay
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
David Yachnin
Luke Lavallee
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec
Marilyn Savard
Frédéric Pouliot
- Recruiting
Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Shawn Byrns-Corbeil
Patrick O Richard
- Recruiting
Thunder Bay Health Sciences Center
Thunder Bay, Ontario
Shalyn Littlefield
Walid Shahrour, MD
- Recruiting
Princess Margaret Hospital
Toronto, Ontario
Thisun Saram
Antonio Finelli
- Recruiting
CIUSSS Mauricie-Centre-du-Québec
Trois-Rivières, Quebec
Marie-Eve Caron
Felix Couture
- Recruiting
Vancouver Prostate Centre
Vancouver, British Columbia
Kate O'Connor
Miles Mannas, MD
- Recruiting
Mens Health Clinic
Winnipeg, Manitoba
Harliv Dhillon
Jay Nayak, MD
- Recruiting
Woodstock hospital
Woodstock, Ontario
Rachel Gutschon
Philippe Violette, MD
France1 site, 1 recruiting
- Recruiting
CHU Bordeaux (URO-CCR)
Bordeaux
Solène Ricard
Jean-Christophe Bernhard, MD
About this study
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.
Read the detailed description
Background: One in three patients over 60 years old will be diagnosed with a renal cyst following abdominal imaging. Traditionally, experts have recommended that complex cystic lesions (also known as Bosniak III - IV cysts) should be surgically removed, but recent evidences suggest that many are benign or have low metastatic potential. Thus, active surveillance which involves close follow-up of a patient's condition, was proposed as a tradeoff option to surgery.
Design: Multicenter observational longitudinal prospective cohort study
Objectives: The goal of this multicenter project is to conduct a prospective study with a 5-year follow-up to confirm the oncologic outcomes of active surveillance in the management of complex cysts. The main objectives are: 1) to compare the 5-year cancer specific survival between cysts managed by surgery and active surveillance; 2) to evaluate disease progression; 3) to evaluate patient's well-being according to each management strategy; and 4) to compare the 5-year healthcare cost of both management approaches.
Study population: Patients incidentally diagnosed with a Bosniak III and/or IV cysts, who are deemed to have at least 5 years of life, and who opted to be managed by either surgery or active surveillance. (N=330)
Follow-up: Patients will DECIDE if they want to have a surgery or to be followed by active surveillance. All patients will be followed as per standard of care with either semi-annual and annual visits. Research visits will serve to assess vital status and quality of life scores (through validated questionnaires). Patients on active surveillance will also be assessed for cyst progression and might be offered invasive or systemic therapy if progression is observed.
- Conditions
- Complex Renal Cyst
- Being tested
- Active surveillance, Surgery
- Keywords
- renal cyst, complex cyst, Bosniak III, Bosniak IV, renal masses, active surveillance, monitoring, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceProcedure or surgery
Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)
SurgeryProcedure or surgery
Per standard of care: partial or full resection of the kidney, imaging annually
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Active surveillance | |
| 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. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year cancer-specific survival
Defined as kidney cancer survival 5 years after the enrollment
Measured: 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
Defined as survival 5 years after enrollment
Measured: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
2-year overall survival
Defined as survival 2 years after enrollment
Measured: from the date of enrollment (defined by signed consent) up to 2 years of follow-up
2-year cancer-specific survival
Defined as kidney cancer survival 2 years after the enrollment
Measured: from the date of enrollment (defined by signed consent) up to 2 years of follow-up
Treatment-free survival
Defined as survival without treatment (in active surveillance group)
Measured: from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up
Discontinuation rate
Defined as the number of people who discontinued active surveillance at the end of the study (over the total)
Measured: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
Tumor growth rate
Defined by change in volume (cm3 ) and change in maximal diameter measured over time (years). Volume will be calculated using the formula for ellipsoid volume: 0.5326 x length x width x height.
Measured: if there is a progression, at the time of imaging (undefined, between 6 months and 5 years post-enrollment)
Tumor progression rate
Defined as the percentage of patients with tumors that have met our pre-specified progression endpoints
Measured: if there is a progression, at the time of imaging (undefined, between 3 months and 5 years post-enrollment)
Time to tumor progression (Progression-free survival)
Defined as the time from the date of enrollment to the date where an individual experienced tumor progression or censoring due to lost to follow-up or the end of follow-up period
Measured: range of time from enrollment to progression (undefined, between 3 months and 5 years post-enrollment) or end of follow-up (5 years post-enrollment)
Patient and tumor characteristics in correlation with cancer-specific death
Defined as demographic (i.e. age, sex, comorbidities, medical history, etc) and tumor characteristics (i.e. tumor size, tumor complexity, etc) associated with kidney cancer deaths
Measured: at the baseline visit (no more than 30 days after signed consent)
Patient and tumor characteristics in correlation with disease progression
Defined as demographic (i.e. age, sex, comorbidities, medical history, etc) and tumor characteristics (i.e. tumor size, tumor complexity, etc) associated with disease progression.
Measured: at the baseline visit (no more than 30 days after signed consent)
Perceived health change over time
Defined as the change in EQ5D-5L scores over time (enrollment to censoring due to lost of follow-up or the end of follow-up period).
Measured: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Quality of life change over time
Defined as the change in short form health survey (SF-12) scores over time (enrollment to censoring due to lost of follow-up or the end of follow-up period).
Measured: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Anxiety change over time
Defined as the change in Hospital Anxiety and Depression Scale (HADS) scores over time (enrollment to censoring due to lost of follow-up or the end of follow-up period).
Measured: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Health cost
Defined as the total direct (patients) and indirect (healthcare system) cost associated with the management of a complex cyst according to each treatment strategy (active surveillance and surgery).
Measured: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start2 Feb 2021
- Primary completion20 Dec 2029 (estimated)
- Study completion20 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Renal CystStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick O Richard, MD,MSc,FRCSC, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558593
- Sponsor's protocol ID
- 2020-3522
- Acronym
- SOCRATIC
- Status last verified
- May 2026
- First submitted
- 31 Aug 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Complex Renal Cysts - The SOCRATIC Study
- ClinicalTrials.gov ID
- NCT04558593
- Acronym / sponsor ID
- SOCRATIC / 2020-3522
- Conditions
- Complex Renal Cyst
- Keywords
- renal cyst, complex cyst, Bosniak III, Bosniak IV, renal masses, active surveillance, monitoring, surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 20 Sep 2031 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: One in three patients over 60 years old will be diagnosed with a renal cyst following abdominal imaging. Traditionally, experts have recommended that complex cystic lesions (also known as Bosniak III - IV cysts) should be surgically removed, but recent evidences suggest that many are benign or have low metastatic potential. Thus, active surveillance which involves close follow-up of a patient's condition, was proposed as a tradeoff option to surgery.
Design: Multicenter observational longitudinal prospective cohort study
Objectives: The goal of this multicenter project is to conduct a prospective study with a 5-year follow-up to confirm the oncologic outcomes of active surveillance in the management of complex cysts. The main objectives are: 1) to compare the 5-year cancer specific survival between cysts managed by surgery and active surveillance; 2) to evaluate disease progression; 3) to evaluate patient's well-being according to each management strategy; and 4) to compare the 5-year healthcare cost of both management approaches.
Study population: Patients incidentally diagnosed with a Bosniak III and/or IV cysts, who are deemed to have at least 5 years of life, and who opted to be managed by either surgery or active surveillance. (N=330)
Follow-up: Patients will DECIDE if they want to have a surgery or to be followed by active surveillance. All patients will be followed as per standard of care with either semi-annual and annual visits. Research visits will serve to assess vital status and quality of life scores (through validated questionnaires). Patients on active surveillance will also be assessed for cyst progression and might be offered invasive or systemic therapy if progression is observed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active surveillance | – | Procedure: Active surveillance220 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 | – | Procedure: Surgery110 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance
Key inclusion criteria (10 listed)
- 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;
- life expectancy >5 years (by physician's estimate);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active surveillancePer standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years) | Procedure or surgery | active surveillance |
| SurgeryPer standard of care: partial or full resection of the kidney, imaging annually | Procedure or surgery | surgery |
Primary outcome
5-year cancer-specific survival
Time frame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
Defined as kidney cancer survival 5 years after the enrollment
14 secondary outcomes
5-year overall survival
Time frame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
2-year overall survival
Time frame: from the date of enrollment (defined by signed consent) up to 2 years of follow-up
2-year cancer-specific survival
Time frame: from the date of enrollment (defined by signed consent) up to 2 years of follow-up
Treatment-free survival
Time frame: from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up
Discontinuation rate
Time frame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
Tumor growth rate
Time frame: if there is a progression, at the time of imaging (undefined, between 6 months and 5 years post-enrollment)
Tumor progression rate
Time frame: if there is a progression, at the time of imaging (undefined, between 3 months and 5 years post-enrollment)
Time to tumor progression (Progression-free survival)
Time frame: range of time from enrollment to progression (undefined, between 3 months and 5 years post-enrollment) or end of follow-up (5 years post-enrollment)
Patient and tumor characteristics in correlation with cancer-specific death
Time frame: at the baseline visit (no more than 30 days after signed consent)
Patient and tumor characteristics in correlation with disease progression
Time frame: at the baseline visit (no more than 30 days after signed consent)
Perceived health change over time
Time frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Quality of life change over time
Time frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Anxiety change over time
Time frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Health cost
Time frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick O Richard, MD,MSc,FRCSC principal investigator
Université de Sherbrooke
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Renal Cyst, run by Université de Sherbrooke at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Tetu (819-346-1110 ext. 15571, amelie.tetu.ciussse-chus@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year cancer-specific survival (time frame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.