Status:
NOT_YET_RECRUITING
Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Cystic Renal Disease
Kidney Cancer
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
The incidence of renal cysts is rising due to increased abdominal imaging. Renal complicated cysts have been traditionally classified according to the Bosniak classification, which distinguishes cysti...
Eligibility Criteria
Inclusion
- A sporadic single CM of Bosniak 3 according to the Bosniak Classification v.2019 is diagnosed with CT or MRI
- Maximal diameter of CM 10-70 mm
- Age ≥50 years
- ECOG performance status \<2
- Life expectancy ≥5 years
- Patient is fit to undergo surgery and AS.
- Patient understands a national language or English
- Signed informed consent
Exclusion
- Genetic syndromes associated with RCC
- Previously or simultaneously diagnosed and pathologically verified RCC
- Previously or simultaneously radiographically identified solid mass or CM of Bosniak 3/4 with diameter ≥10mm
- The target CM of Bosniak 3 has progressed in sequential imaging from Bosniak 1-2F
- Presence of radiographic findings which are suspect for nodal or distant metastatic disease
- Symptomatic CM
- Kidney insufficiency (GFR\<55 ml/min/1,73m2)
- Patients who have contraindications for both CT and MRI imaging. . Anatomically solitary kidney
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 11 2036
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04670887
Start Date
March 15 2021
End Date
January 11 2036
Last Update
February 17 2021
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