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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02346435
Other study ID # NA_00016036
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2009
Est. completion date January 2024

Study information

Verified date October 2021
Source Johns Hopkins University
Contact Nirmish Singla
Phone 410-502-3692
Email nsingla2@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-specific survival Safety and Efficacy of active surveillance and delayed intervention for the SRM, measured by disease-free survival at 5-years. 5 years
Secondary Objective Safety and Tolerability of Percutaneous Renal Biopsy Measured by observed total (minor and major) complications compared to historical complication rates for this procedure. 5 years
Secondary Quality-of-life outcomes for patients undergoing AS versus definitive therapy. Measured by SF12 Questionnaire at enrollment, 6 and 12 months and annually thereafter. 5 years
Secondary 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. 5 years
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