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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Neoplasm

Detailed Description

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 (Estimated): 600

Contacts and Locations

• Study Contact: Name: Nirmish Singla; Phone Number: 410-502-3692; Email: nsingla2@jhmi.edu
• Study Contact Backup: Name: Tina Driscoll; Email: twlajni1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Sub-Investigator: Phillip M Pierorazio, MD
      • Principal Investigator: Mohamad E Allaf, MD, MBA
      • Contact: Phillip M Pierorazio, MD; Phone Number: 4105025984; Email: philpierorazio@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, <=4cm).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: National Comprehensive Cancer Network
• Investigators: Principal Investigator: Mohamad E Allaf, MD, MBA, Johns Hopkins University; Principal Investigator: Nirmish Singla, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimated): January 27, 2015

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: active surveillance; small renal mass
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: 17821; NA_00016036 (Other Identifier: AbramsonCC); 850179 (Other Identifier: UPenn IRB)