Actively Recruiting
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-03-05
600
Participants Needed
1
Research Sites
N/A
Total Duration
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
N
National Comprehensive Cancer Network
Collaborating Sponsor
Researchers are evaluating the safety and effectiveness of active surveillance compared to immediate intervention for patients with small kidney tumors (less than or equal to 4 cm) found incidentally. This observational study aims to prospectively compare these approaches to better understand their impact on disease-specific survival and patient quality of life. The study is led by the Abramson Cancer Center at Penn Medicine and includes adult patients aged 18 to 100 years. Participants are offered either active surveillance or immediate intervention. Active surveillance patients are followed closely with regular imaging, blood tests, and quality of life questionnaires according to a set protocol. Patients undergoing immediate intervention may have surgery such as partial or radical nephrectomy or energy ablation, and their follow-up care includes quality of life assessments at the discretion of their surgeon. Some patients initially on surveillance who meet progression criteria or choose to undergo treatment may cross over to delayed intervention. During the study, participants will have ongoing evaluations including imaging and blood work, along with quality of life questionnaires to monitor their condition and treatment impact. Researchers will measure outcomes such as disease-specific survival over five years, safety and tolerability of kidney biopsies, and quality of life differences between treatment groups. The study also aims to identify selection criteria for active surveillance. Participants may be followed for long-term outcomes, with the total study duration extending through 2028.
CONDITIONS
The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants who choose active surveillance are followed with serial imaging, blood work, and quality of life questionnaires as per the protocol.
Regular visits for imaging, blood work, and questionnaires as per protocol
Duration - Up to 5 years
Participants who undergo immediate intervention such as partial or radical nephrectomy or energy ablation are followed at the discretion of their surgeon with quality of life appointments and questionnaires.
Follow-up visits for quality of life assessments as scheduled by surgeon
Duration - Up to 5 years
Participants initially under active surveillance who meet progression criteria or choose delayed intervention undergo treatment and are followed similarly to intervention patients.
Follow-up visits similar to intervention participants
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
N
Nirmish Singla
T
Tina Driscoll
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Khalid Y Alkhatib, Joseph G Cheaib, Maximilian Pallauf...
https://pubmed.ncbi.nlm.nih.gov/40262276