Kidney Neoplasm Clinical Trial
— DISSRMOfficial title:
The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
NCT number | NCT02346435 |
Other study ID # | NA_00016036 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2009 |
Est. completion date | January 2024 |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Comprehensive Cancer Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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