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Surveillance of Complex Renal Cysts - The SOCRATIC Study (SOCRATIC)

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ClinicalTrials.gov Identifier: NCT04558593
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : March 8, 2022
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Université de Sherbrooke

Tracking Information
First Submitted Date August 31, 2020
First Posted Date September 22, 2020
Last Update Posted Date March 8, 2022
Actual Study Start Date February 2, 2021
Estimated Primary Completion Date December 20, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 15, 2020)
  • 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) ]
    Defined as survival 5 years after enrollment
  • 2-year overall survival [ Time Frame: from the date of enrollment (defined by signed consent) up to 2 years of follow-up ]
    Defined as survival 2 years after enrollment
  • 2-year cancer-specific survival [ Time Frame: from the date of enrollment (defined by signed consent) up to 2 years of follow-up ]
    Defined as kidney cancer survival 2 years after the enrollment
  • Treatment-free survival [ Time Frame: from the date of enrollment (defined by signed consent) up to 2 and 5 years of follow-up ]
    Defined as survival without treatment (in active surveillance group)
  • Discontinuation rate [ Time Frame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years) ]
    Defined as the number of people who discontinued active surveillance at the end of the study (over the total)
  • Tumor growth rate [ Time Frame: if there is a progression, at the time of imaging (undefined, between 6 months and 5 years post-enrollment) ]
    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.
  • Tumor progression rate [ Time Frame: if there is a progression, at the time of imaging (undefined, between 3 months and 5 years post-enrollment) ]
    Defined as the percentage of patients with tumors that have met our pre-specified progression endpoints
  • 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) ]
    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
  • Patient and tumor characteristics in correlation with cancer-specific death [ Time Frame: at the baseline visit (no more than 30 days after signed consent) ]
    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
  • Patient and tumor characteristics in correlation with disease progression [ Time Frame: at the baseline visit (no more than 30 days after signed consent) ]
    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.
  • Perceived health change over time [ Time Frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment) ]
    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).
  • Quality of life change over time [ Time Frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment) ]
    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).
  • Anxiety change over time [ Time Frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment) ]
    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).
  • Health cost [ Time Frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment) ]
    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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surveillance of Complex Renal Cysts - The SOCRATIC Study
Official Title Surveillance of Complex Renal Cysts - The SOCRATIC Study
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 evaluate vital status and quality of life scores (through validated questionnaires). Patients on active surveillance will also be assessed for cyst progression and will be offered invasive or systemic therapy if progression is observed.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Complex Renal Cyst
Intervention
  • Procedure: Active surveillance
    Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)
  • Procedure: Surgery
    Per standard of care: partial or full resection of the kidney
Study Groups/Cohorts
  • 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
    Intervention: 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.
    Intervention: Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 15, 2020)
330
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 20, 2030
Estimated Primary Completion Date December 20, 2029   (Final data collection date for primary outcome measure)
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) ≤3mm for Bosniak III cysts and <10mm for Bosniak IV ;
  • solid component acute margin of protrusion ≤2 cm in maximal diameter for Bosniak IV cysts;
  • life expectancy >5 years (by physician's estimate);
  • diagnosis ≤ 6 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)
  • refusing to be co-enrolled in CKCis registry (when applicable in CKCis participating centers)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Amelie Tetu 819-346-1110 ext 15571 amelie.tetu.ciussse-chus@ssss.gouv.qc.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04558593
Other Study ID Numbers 2020-3522
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Université de Sherbrooke
Original Responsible Party Same as current
Current Study Sponsor Université de Sherbrooke
Original Study Sponsor Same as current
Collaborators Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick O Richard, MD,MSc,FRCSC Université de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date March 2022