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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00016036 | Other Identifier | AbramsonCC | |
| 850179 | Other Identifier | UPenn IRB |
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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Surveillance | |||
| Immediate Intervention | May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation. | ||
| Crossover (Delayed Intervention) | Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, <=4cm).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nirmish Singla | Contact | 410-502-3692 | nsingla2@jhmi.edu | |
| Tina Driscoll | Contact | twlajni1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mohamad E Allaf, MD, MBA | Johns Hopkins University | Principal Investigator |
| Nirmish Singla | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40262276 | Derived | Alkhatib KY, Cheaib JG, Pallauf M, Alam R, Patel HD, Wlajnitz T, Singla N, Chang P, Wagner AA, Pavlovich CP, McKiernan JM, Guzzo TJ, Allaf ME, Pierorazio PM. Active Surveillance vs Primary Intervention for Clinical T1a Kidney Tumors: 12-Year Experience of the Delayed Intervention and Surveillance for Small Renal Masses Prospective Comparative Study. J Urol. 2025 Aug;214(2):197-209. doi: 10.1097/JU.0000000000004583. Epub 2025 Apr 22. |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |