NCT04670887Not yet recruiting
Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts
A Prospective Multicenter Trial Comparing Surgery Versus Active Surveillance In Patients With Bosniak 3 Renal Cystic Masses, A NoRenCa And FinnKidney Study
Source: ClinicalTrials.gov · Last updated 17 Feb 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 cystic masses by specific features of walls and septa. The categories I and II are benign and class IIF most probably benign but needs a short radiological follow-up. Categories III and IV have been traditionally operated due to the increased risk of renal cell carcinoma. However, recently published studies show that approximately 50% of the operated Bosniak III cystic masses are benign, which means that half of the cases are overtreated by surgery. It has also been shown that surgical pathology of stable Bosniak IIF cysts is malignant in less than 1%, while the cysts, which are upgraded to higher Bosniak classes will show malignant surgical pathology in 85%. So far, there is lack of prospective data on active surveillance in Bosniak III cystic masses. The aim of the study is to compare active surveillance and surgery in patients with Bosniak III renal cystic masses. Patients will be randomized in active surveillance or immediate surgical excision of a cystic mass. In the active surveillance group, patients are followed according to the study protocol for 10 years and treated with delayed surgery if the cystic mass upgrades into Bosniak IV/solid, becomes symptomatic or grows over a preclassified threshold. The primary objective is to compare surgical pathology between patients treated with immediate surgery versus delayed surgery. According to recent retrospective data, active surveillance of Bosniak III cystic masses is reasonable and oncologically safe. Therefore a prospective randomized controlled trial is needed to get high level evidence to support a change in the treatment strategy. The study may significantly reduce unnecessary operations performed in patients with Bosniak III cystic masses.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 26 Nov 2020
- Start date
- 15 Mar 2021
- Primary completion date
- 11 Jan 2024
- Lead sponsor
- Helsinki University Central Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT04670887
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 15 Mar 2021 to the primary completion date, 11 Jan 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously or simultaneously diagnosed and pathologically verified RCC
- Previously or simultaneously radiographically identified solid mass or CM of Bosniak 3/4 with diameter ≥10mm
Other illness
- Genetic syndromes associated with RCC
- Presence of radiographic findings which are suspect for nodal or distant metastatic disease
Lab values
- Kidney insufficiency (GFR\<55 ml/min/1,73m2)
Other
- The target CM of Bosniak 3 has progressed in sequential imaging from Bosniak 1-2F
- Symptomatic CM
- Patients who have contraindications for both CT and MRI imaging. . Anatomically solitary kidney
Who the study is looking for
- 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
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.