Clinical trial NCT04558593: Surveillance of Complex Renal Cysts - The SOCRATIC Study
Official title: Surveillance of Complex Renal Cysts - The SOCRATIC Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complex Renal Cyst
Keywords: renal cyst
complex cyst
Bosniak III
Bosniak IV
renal masses
active surveillance
monitoring
surgery
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients incidentally diagnosed with a Bosniak III or IV cysts and who opted to be managed by either surgery or active surveillance

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 5-year cancer-specific survival
timeFrame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
Secondary outcomes:
measure: 5-year overall survival
timeFrame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
measure: 2-year overall survival
timeFrame: from the date of enrollment (defined by signed consent) up to 2 years of follow-up
measure: 2-year cancer-specific survival
timeFrame: from the date of enrollment (defined by signed consent) up to 2 years of follow-up
measure: Treatment-free survival
timeFrame: from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up
measure: Discontinuation rate
timeFrame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
measure: Tumor growth rate
timeFrame: if there is a progression, at the time of imaging (undefined, between 6 months and 5 years post-enrollment)
measure: Tumor progression rate
timeFrame: if there is a progression, at the time of imaging (undefined, between 3 months and 5 years post-enrollment)
measure: Time to tumor progression (Progression-free survival)
timeFrame: 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)
measure: Patient and tumor characteristics in correlation with cancer-specific death
timeFrame: at the baseline visit (no more than 30 days after signed consent)
measure: Patient and tumor characteristics in correlation with disease progression
timeFrame: at the baseline visit (no more than 30 days after signed consent)
measure: Perceived health change over time
timeFrame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
measure: Quality of life change over time
timeFrame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
measure: Anxiety change over time
timeFrame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
measure: Health cost
timeFrame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
Other outcomes:
measure: Radiomic
timeFrame: On diagnostic imaging, up to 12 months prior consent form
Locations:
city: Calgary
country: Canada
facility: Prostate Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Northern Alberta Urology Center
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Mens Health Clinic
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St-Joseph's Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Woodstock
country: Canada
facility: Woodstock hospital
state: Ontario
city: Lévis
country: Canada
facility: Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis
state: Quebec
city: Montreal
country: Canada
facility: CHUM
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont (CISSS-EIMtl)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
state: Quebec
city: Bordeaux
country: France
facility: CHU Bordeaux (URO-CCR)
Study officials:
affiliation: Université de Sherbrooke
name: Patrick O Richard, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
References: