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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

Study Description
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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.

Condition or disease
Kidney Neoplasm

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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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
Study Population
All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, <=4cm).
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Phillip M Pierorazio, MD 410 502 5984 philpierorazio@jhmi.edu
Contact: Tina Driscoll twlajni1@jhmi.edu

Locations
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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         
Sponsors and Collaborators
Johns Hopkins University
National Comprehensive Cancer Network
Investigators
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Principal Investigator: Mohamad E Allaf, MD, MBA Johns Hopkins University
Principal Investigator: Phillip M Pierorazio, MD Johns Hopkins University
More Information
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Additional Information:

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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: November 8, 2019
Last Verified: November 2019
Keywords provided by Johns Hopkins University:
small renal mass
active surveillance
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Kidney Diseases
Urologic Diseases