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

Recruiting

• Conditions: Kidney Neoplasm

• Registration Number: NCT02346435
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-specific survival	5 years	Safety and Efficacy of active surveillance and delayed intervention for the SRM, measured by disease-free survival at 5-years.

Secondary Outcome Measures

Name	Time	Method
Objective Safety and Tolerability of Percutaneous Renal Biopsy	5 years	Measured by observed total (minor and major) complications compared to historical complication rates for this procedure.
Quality-of-life outcomes for patients undergoing AS versus definitive therapy.	5 years	Measured by SF12 Questionnaire at enrollment, 6 and 12 months and annually thereafter.
To determine objective selection criteria for active surveillance.	5 years	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.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States