Surveillance of Complex Renal Cysts - The SOCRATIC Study

Complex Renal Cyst Clinical Trial

— SOCRATIC  

Official title:

Surveillance of Complex Renal Cysts - The SOCRATIC Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558593
• Other study ID #: 2020-3522
• Status: Recruiting
• Start date: February 2, 2021
• Est. completion date: September 20, 2031

Study information

• Verified date: March 2024
• Source: Université de Sherbrooke
• Contact: Amelie Tetu
• Phone: 819-346-1110
• Email: amelie.tetu.ciussse-chus[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: September 20, 2031
• Est. primary completion date: December 20, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Complex Renal Cyst
• Cysts

Intervention

Procedure:
• Active surveillance
Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)
• Surgery
Per standard of care: partial or full resection of the kidney, imaging annually

Locations

Country	Name	City	State
Canada	Prostate Cancer Center	Calgary	Alberta
Canada	Northern Alberta Urology Center	Edmonton	Alberta
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	St-Joseph's Hospital	Hamilton	Ontario
Canada	Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis	Lévis	Quebec
Canada	CHUM	Montreal	Quebec
Canada	Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Québec - Université Laval	Québec	Quebec
Canada	Centre de recherche du Centre hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Thunder Bay Health Sciences Center	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Vancouver Prostate Centre	Vancouver
Canada	Woodstock hospital	Woodstock	Ontario
France	CHU Bordeaux (URO-CCR)	Bordeaux

Sponsors (2)

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

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiomic	Predictive ability of radiomics (comparison between imaging and clinical/research data)	On diagnostic imaging, up to 12 months prior consent form
Primary	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	5-year overall survival	Defined as survival 5 years after enrollment	from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
Secondary	2-year overall survival	Defined as survival 2 years after enrollment	from the date of enrollment (defined by signed consent) up to 2 years of follow-up
Secondary	2-year cancer-specific survival	Defined as kidney cancer survival 2 years after the enrollment	from the date of enrollment (defined by signed consent) up to 2 years of follow-up
Secondary	Treatment-free survival	Defined as survival without treatment (in active surveillance group)	from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up
Secondary	Discontinuation rate	Defined as the number of people who discontinued active surveillance at the end of the study (over the total)	from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
Secondary	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.	if there is a progression, at the time of imaging (undefined, between 6 months and 5 years post-enrollment)
Secondary	Tumor progression rate	Defined as the percentage of patients with tumors that have met our pre-specified progression endpoints	if there is a progression, at the time of imaging (undefined, between 3 months and 5 years post-enrollment)
Secondary	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	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)
Secondary	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	at the baseline visit (no more than 30 days after signed consent)
Secondary	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.	at the baseline visit (no more than 30 days after signed consent)
Secondary	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).	range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Secondary	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).	range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Secondary	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).	range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Secondary	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).	range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)