The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry

Conditions
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Kidney Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have a solid, enhancing renal mass ≤4cm at its greatest dimension found on incidental scanning in the last 6 months. Age ≥ 18 and able to read, understand and sign informed consent. Must be willing to adhere to the treatment algorithm and time constraints therein. Exclusion Criteria: Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Surveillance<br> | |
| Immediate Intervention<br>May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation. | |
| Crossover (Delayed Intervention)<br>Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific survival | Safety and Efficacy of active surveillance and delayed intervention for the SRM, measured by disease-free survival at 5-years. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Safety and Tolerability of Percutaneous Renal Biopsy | Measured by observed total (minor and major) complications compared to historical complication rates for this procedure. | 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. | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small renal mass, active surveillance