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.
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 Type
OBSERVATIONAL
Enrollment
330
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
Prostate Cancer Center
Calgary, Alberta, Canada
RECRUITINGNorthern Alberta Urology Center
Edmonton, Alberta, Canada
RECRUITINGVancouver Prostate Centre
Vancouver, British Columbia, Canada
RECRUITINGMens Health Clinic
Winnipeg, Manitoba, Canada
RECRUITINGNova Scotia Health Authority
Halifax, Nova Scotia, Canada
RECRUITINGSt-Joseph's Hospital
Hamilton, Ontario, Canada
RECRUITINGThe Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGThunder Bay Health Sciences Center
Thunder Bay, Ontario, Canada
RECRUITINGPrincess Margaret Hospital
Toronto, Ontario, Canada
RECRUITINGWoodstock hospital
Woodstock, Ontario, Canada
RECRUITING...and 8 more locations
5-year cancer-specific survival
Defined as kidney cancer survival 5 years after the enrollment
Time frame: from the date of enrollment (defined by signed consent) to the end of follow-up (up to 5 years)
5-year overall survival
Defined as survival 5 years after enrollment
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
Defined as survival 2 years after enrollment
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
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)
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
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
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
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: range of time from enrollment to end of follow-up (maximum 5 years post-enrollment)
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