Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts

February 16, 2021 updated by: Harry Nisén, Helsinki University Central Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate surgery
Patients undergo excision of a renal mass by partial or radical nephrectomy and will be followed by UISS risk classification.
Procedure: Immediate surgery
Partial or radical nephrectomy is performed as treatment of Bosniak 3 cystic mass
Active Comparator: Active surveillance
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
Procedure: Delayed surgery
Delayed surgery is performed if cystic mass radiologically upgrades into Bosniak 4 or solid mass in the active surveillance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Malignancy rate in surgical pathology
Time Frame: From date of randomization until the date of surgery, assessed up to 120 months
From date of randomization until the date of surgery, assessed up to 120 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cancer specific survival
Time Frame: From date of randomization until the date of death due to renal cancer, assessed up to 120 months
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
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
From date of randomization until the date of death from any cause, assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Harry Nisén, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2021

Primary Completion (Anticipated)

January 11, 2024

Study Completion (Anticipated)

January 11, 2036

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/1556/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

Starting 6 months after publication.

IPD Sharing Access Criteria

Requests are reviewed by the steering committee.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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