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

Kidney Neoplasm Clinical Trial

— DISSRM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02346435
• Other study ID #: NA_00016036
• Status: Recruiting
• Start date: January 2009
• Est. completion date: January 2024

Study information

• Verified date: October 2021
• Source: Johns Hopkins University
• Contact: Nirmish Singla
• Phone: 410-502-3692
• Email: nsingla2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Kidney Neoplasm
• Kidney Neoplasms

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

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