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Recruiting NCT02346435

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

Observational Kidney Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Kidney Neoplasm. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Disease-specific survival [Time frame: 5 years]
Secondary outcome measures (3)
  • Objective Safety and Tolerability of Percutaneous Renal Biopsy [Time frame: 5 years]
  • Quality-of-life outcomes for patients undergoing AS versus definitive therapy. [Time frame: 5 years]
  • To determine objective selection criteria for active surveillance. [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • Johns Hopkins Hospital — Baltimore

Publications

  • Alkhatib KY, Cheaib JG, Pallauf M, Alam R, Patel HD, Wlajnitz T, Singla N, Chang P, Wagner AA, Pavlovich CP, McKiernan JM, Guzzo TJ, Allaf ME, Pierorazio PM. Active Surveillance vs Primary Intervention for Clinical T1a Kidney Tumors: 12-Year Experience of the Delayed Intervention and Surveillance for Small Renal Masses Prospective Comparative Study. J Urol. 2025 Aug;214(2):197-209. doi: 10.1097/JU PMID 40262276

Identifiers

NCT: NCT02346435 · 17821 · NA_00016036 · 850179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗