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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02346435

Acronym

DISSRM

Enrollment

600

Registered

2015-01-27

Start date

2009-01-01

Completion date

2028-01-01

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Neoplasm

Keywords

small renal mass, active surveillance

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTNirmish Singla

nsingla2@jhmi.edu410-502-3692

CONTACTTina Driscoll

twlajni1@jhmi.edu

PRINCIPAL_INVESTIGATORMohamad E Allaf, MD, MBA

Johns Hopkins University

PRINCIPAL_INVESTIGATORNirmish Singla