The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
DISSRM
3 other identifiers
observational
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 6, 2014
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
March 5, 2026
September 1, 2025
19 years
June 6, 2014
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Objective Safety and Tolerability of Percutaneous Renal Biopsy
5 years
Quality-of-life outcomes for patients undergoing AS versus definitive therapy.
5 years
To determine objective selection criteria for active surveillance.
5 years
Study Arms (3)
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.
Eligibility Criteria
All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, \<=4cm).
You may qualify if:
- 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.
You may not qualify if:
- Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (1)
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.
PMID: 40262276DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamad E Allaf, MD, MBA
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Nirmish Singla
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2014
First Posted
January 27, 2015
Study Start
January 1, 2009
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
March 5, 2026
Record last verified: 2025-09