Registry Study Comparing Active Surveillance and Immediate Treatment for Small Kidney Tumors 4 cm or Smaller
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-03-05
600
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
Research Team
N
Nirmish Singla
T
Tina Driscoll
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Must have a solid, enhancing kidney mass 4 cm or smaller found incidentally within the last 6 months.
Age 18 years or older and able to read, understand, and sign informed consent.
Willing to follow the treatment plan and timing required by the study.
You will not qualify if you...
Cannot have suspicion of kidney metastases if diagnosed with another cancer within the past two years.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surveillance
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
Immediate Intervention
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
Crossover (Delayed Intervention)
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
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Registry Study Comparing Active Surveillance and Immediate Treatment for Small Kidney Tumors 4 cm or Smaller
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Published Research Related To This Trial
Active Surveillance vs Primary Intervention for Clinical T1a Kidney Tumors: 12-Year Experience of the Delayed Intervention and Surveillance for Small Renal Masses Prospective Comparative Study.
Khalid Y Alkhatib, Joseph G Cheaib, Maximilian Pallauf...