Retrospective studies indicate that active surveillance for clinically localized, small renal masses (cT1a, \<=4cm) is safe. It is our hypothesis that active surveillance is safe and efficacious when compared prospectively to patients undergoing immediate intervention for their small renal mass.
All patients are offered active surveillance or immediate intervention, as applicable, prior to being offered consent for the DISSRM Registry. All patients are enrolled and followed prospectively. Surveillance patients are followed per protocol with serial imaging, blood work and quality of life questionnaires. Intervention patients are followed at the discretion of the attending surgeon with serial QOL appointments/questionnaires.
Study Type
OBSERVATIONAL
Enrollment
600
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGDisease-specific survival
Safety and Efficacy of active surveillance and delayed intervention for the SRM, measured by disease-free survival at 5-years.
Time frame: 5 years
Objective Safety and Tolerability of Percutaneous Renal Biopsy
Measured by observed total (minor and major) complications compared to historical complication rates for this procedure.
Time frame: 5 years
Quality-of-life outcomes for patients undergoing AS versus definitive therapy.
Measured by SF12 Questionnaire at enrollment, 6 and 12 months and annually thereafter.
Time frame: 5 years
To determine objective selection criteria for active surveillance.
Demographic (i.e. age, sex, race), clinical (i.e. comorbidities, medications, family history) and imaging characteristics (i.e. tumor size, enhancement patterns, tumor complexity) will be used to determine patients most suitable for active surveillance.
Time frame: 5 years
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