The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry (DISSRM)
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ClinicalTrials.gov Identifier: NCT02346435 |
Recruitment Status :
Recruiting
First Posted : January 27, 2015
Last Update Posted : October 19, 2021
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Condition or disease |
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Kidney Neoplasm |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 600 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | January 2024 |

Group/Cohort |
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Active Surveillance |
Immediate Intervention
May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation.
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Crossover (Delayed Intervention)
Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention.
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- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346435
Contact: Nirmish Singla | 410-502-3692 | nsingla2@jhmi.edu | |
Contact: Tina Driscoll | twlajni1@jhmi.edu |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Phillip M Pierorazio, MD 410-502-5984 philpierorazio@jhmi.edu | |
Sub-Investigator: Phillip M Pierorazio, MD | |
Principal Investigator: Mohamad E Allaf, MD, MBA |
Principal Investigator: | Mohamad E Allaf, MD, MBA | Johns Hopkins University | |
Principal Investigator: | Nirmish Singla | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT02346435 |
Other Study ID Numbers: |
NA_00016036 |
First Posted: | January 27, 2015 Key Record Dates |
Last Update Posted: | October 19, 2021 |
Last Verified: | October 2021 |
small renal mass active surveillance |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Kidney Diseases Urologic Diseases |