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
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||600 participants|
|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|
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.
- 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.
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: Phillip M Pierorazio, MD||410 502 firstname.lastname@example.org|
|Contact: Tina Driscollemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Phillip M Pierorazio, MD 410-502-5984 firstname.lastname@example.org|
|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:||Phillip M Pierorazio, MD||Johns Hopkins University|