Cystic Renal DiseaseNCT04670887
Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts
A study testing Delayed surgery and Immediate surgery in people with Cystic Renal Disease and Kidney Cancer, run by Helsinki University Central Hospital.
Trial 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 cystic masses by specific features of walls and septa. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Cystic Renal Disease, Kidney Cancer, Surgery
- What is being tested?
- Delayed surgery and Immediate surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2021to 11 Jan 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Multicenter Trial Comparing Surgery Versus Active Surveillance In Patients With Bosniak 3 Renal Cystic Masses, A NoRenCa And FinnKidney Study
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.
- Conditions
- Cystic Renal Disease, Kidney Cancer, Surgery
- Being tested
- Delayed surgery, Immediate surgery
- Keywords
- Bosniak classification, Active surveillance, Renal cystic mass, Cystic renal cell carcinoma
- Medical subject headings
- Kidney Diseases, Cystic, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed surgeryProcedure or surgery
Delayed surgery is performed if cystic mass radiologically upgrades into Bosniak 4 or solid mass in the active surveillance.
Immediate surgeryProcedure or surgery
Partial or radical nephrectomy is performed as treatment of Bosniak 3 cystic mass
| Study group | Role | What they receive |
|---|---|---|
| Immediate surgery | Active comparator | Patients undergo excision of a renal mass by partial or radical nephrectomy and will be followed by UISS risk classification. Receives: Procedure: Immediate surgery |
| Active surveillance | Active comparator | Patients enter active surveillance protocol. Delayed surgery on active surveillance will be recommended if progression from Bosniak 3 to 4 or a solid mass is noted on imaging by radiologist Receives: Procedure: Delayed surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignancy rate in surgical pathology
Measured: From date of randomization until the date of surgery, assessed up to 120 months
Secondary outcomes (3)
Cancer specific survival
Measured: From date of randomization until the date of death due to renal cancer, assessed up to 120 months
Progression-free survival
Measured: From date of randomization until the date of first documented progression, assessed up to 120 months
Overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Mar 2021 (estimated)
- Primary completion11 Jan 2024 (estimated)
- Study completion11 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harry Nisén, Helsinki University Central Hospital
- Investigators
- Harry Nisén, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670887
- Sponsor's protocol ID
- HUS/1556/2020
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Trial Comparing Surgery Versus Active Surveillance In Patients With Bosniak 3 Renal Cystic Masses, A NoRenCa And FinnKidney Study
- ClinicalTrials.gov ID
- NCT04670887
- Acronym / sponsor ID
- HUS/1556/2020
- Conditions
- Cystic Renal Disease, Kidney Cancer, Surgery
- Keywords
- Bosniak classification, Active surveillance, Renal cystic mass, Cystic renal cell carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 11 Jan 2024 (estimated)
- Study completion
- 11 Jan 2036 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate surgery | Active comparator | Procedure: Immediate surgeryPatients undergo excision of a renal mass by partial or radical nephrectomy and will be followed by UISS risk classification. |
| Active surveillance | Active comparator | Procedure: Delayed surgeryPatients enter active surveillance protocol. Delayed surgery on active surveillance will be recommended if progression from Bosniak 3 to 4 or a solid mass is noted on imaging by radiologist |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed surgeryDelayed surgery is performed if cystic mass radiologically upgrades into Bosniak 4 or solid mass in the active surveillance. | Procedure or surgery | Active surveillance |
| Immediate surgeryPartial or radical nephrectomy is performed as treatment of Bosniak 3 cystic mass | Procedure or surgery | Immediate surgery |
Primary outcome
Malignancy rate in surgical pathology
Time frame: From date of randomization until the date of surgery, assessed up to 120 months
3 secondary outcomes
Cancer specific survival
Time frame: From date of randomization until the date of death due to renal cancer, assessed up to 120 months
Progression-free survival
Time frame: From date of randomization until the date of first documented progression, assessed up to 120 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harry Nisén principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Delayed surgery and Immediate surgery in people with Cystic Renal Disease and Kidney Cancer, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harry Nisén, Adj. professor (+35894711, harry.nisen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malignancy rate in surgical pathology (time frame: From date of randomization until the date of surgery, assessed up to 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.