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

NCT ID: NCT02346435

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Kidney Neoplasm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Active Surveillance

No interventions assigned to this group

Immediate Intervention

May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation.

No interventions assigned to this group

Crossover (Delayed Intervention)

Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Comprehensive Cancer Network

NETWORK

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamad E Allaf, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Nirmish Singla

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nirmish Singla

Role: CONTACT

410-502-3692

Tina Driscoll

Role: CONTACT

Facility Contacts

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Phillip M Pierorazio, MD

Role: primary

410-502-5984

Other Identifiers

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NA_00016036

Identifier Type: OTHER

Identifier Source: secondary_id

850179

Identifier Type: OTHER

Identifier Source: secondary_id

17821

Identifier Type: -

Identifier Source: org_study_id

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