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NCT Number: NCT02346435

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

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.

Recruiting

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Key information

Conditions

Kidney Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Mohamad E Allaf, MD, MBA

PRINCIPAL_INVESTIGATOR

Phillip M Pierorazio, MD

CONTACT

[email protected]

4105025984

Phillip M Pierorazio, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Disease-specific survival

    Time frame: 5 years

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

Secondary outcomes

  1. Objective Safety and Tolerability of Percutaneous Renal Biopsy

    Time frame: 5 years

    Measured by observed total (minor and major) complications compared to historical complication rates for this procedure.

  2. Quality-of-life outcomes for patients undergoing AS versus definitive therapy.

    Time frame: 5 years

    Measured by SF12 Questionnaire at enrollment, 6 and 12 months and annually thereafter.

  3. To determine objective selection criteria for active surveillance.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nirmish Singla

CONTACT

[email protected]

410-502-3692

Tina Driscoll

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Comprehensive Cancer Network

Registry information

Acronym: DISSRM

Important dates

Study start
2009
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2015
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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