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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02346435
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date June 6, 2014
First Posted Date January 27, 2015
Last Update Posted Date November 8, 2019
Study Start Date January 2009
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 20, 2015)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
Official Title The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
Brief 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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, <=4cm).
Condition Kidney Neoplasm
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 20, 2015)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Phillip M Pierorazio, MD 410 502 5984 philpierorazio@jhmi.edu
Contact: Tina Driscoll twlajni1@jhmi.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02346435
Other Study ID Numbers NA_00016036
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators National Comprehensive Cancer Network
Investigators
Principal Investigator: Mohamad E Allaf, MD, MBA Johns Hopkins University
Principal Investigator: Phillip M Pierorazio, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date November 2019