Kidney NeoplasmDISSRMNCT02346435
The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
An observational study of Kidney Neoplasm, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Neoplasm
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, <=4cm).
Who may be able to join
- 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.
Who cannot join
- Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tina Driscoll contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Phillip M Pierorazio, MD, 4105025984, philpierorazio@jhmi.edu
Phillip M Pierorazio, MD
About this study
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.
Read the 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.
- Conditions
- Kidney Neoplasm
- Keywords
- small renal mass, active surveillance
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | Not described | |
| Immediate Intervention | May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation. | |
| Crossover (Delayed Intervention) | Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific survival
Safety and Efficacy of active surveillance and delayed intervention for the SRM, measured by disease-free survival at 5-years.
Measured: 5 years
Secondary outcomes (3)
Objective Safety and Tolerability of Percutaneous Renal Biopsy
Measured by observed total (minor and major) complications compared to historical complication rates for this procedure.
Measured: 5 years
Quality-of-life outcomes for patients undergoing AS versus definitive therapy.
Measured by SF12 Questionnaire at enrollment, 6 and 12 months and annually thereafter.
Measured: 5 years
To determine objective selection criteria for active surveillance.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2009
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Mohamad E Allaf, MD, MBA, Principal investigator, Johns Hopkins UniversityNirmish Singla, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346435
- Sponsor's protocol ID
- 17821
- Other IDs
- NA_00016036, 850179
- Acronym
- DISSRM
- Status last verified
- Sep 2025
- First submitted
- 6 Jun 2014
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
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.0000000000004583. Epub 2025 Apr 22.
PubMed 40262276
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
- ClinicalTrials.gov ID
- NCT02346435
- Acronym / sponsor ID
- DISSRM / 17821
- Conditions
- Kidney Neoplasm
- Keywords
- small renal mass, active surveillance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Jan 2009
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | – | – |
| Immediate Intervention | – | –May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation. |
| Crossover (Delayed Intervention) | – | –Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, <=4cm).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 40262276Alkhatib 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.0000000000004583. Epub 2025 Apr 22.
Related trials for Kidney Neoplasm
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tina Driscoll contact
Mohamad E Allaf, MD, MBA principal investigator
Johns Hopkins University
Nirmish Singla principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasm, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nirmish Singla (410-502-3692, nsingla2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-specific survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.