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

• ClinicalTrials.gov Identifier: NCT02346435
• Recruitment Status: Recruiting
• First Posted: January 27, 2015
• Last Update Posted: October 19, 2021
• Sponsor: Johns Hopkins University
• Collaborator: National Comprehensive Cancer Network
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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

• 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

Groups and Cohorts

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

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

• 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

Contacts

Contact: Nirmish Singla; 410-502-3692; nsingla2@jhmi.edu

Contact: Tina Driscoll; twlajni1@jhmi.edu

Locations

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

• Principal Investigator: Mohamad E Allaf, MD, MBA; Johns Hopkins University
• Principal Investigator: Nirmish Singla; Johns Hopkins University

More Information

Additional Information:

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02346435
• Other Study ID Numbers: NA_00016036
• First Posted: January 27, 2015
• Last Update Posted: October 19, 2021
• Last Verified: October 2021

Keywords provided by Johns Hopkins University:

small renal mass; active surveillance

Additional relevant MeSH terms:

Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Kidney Diseases; Urologic Diseases