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

NCT04670887 | Not Yet Recruiting DMC

• 1 other identifier: HUS/1556/2020
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Bosniak classification; Active surveillance; Renal cystic mass; Cystic renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Malignancy rate in surgical pathology

  From date of randomization until the date of surgery, assessed up to 120 months

Secondary Outcomes (3)

• Cancer specific survival

  From date of randomization until the date of death due to renal cancer, assessed up to 120 months

• Progression-free survival

  From date of randomization until the date of first documented progression, assessed up to 120 months

• Overall survival

  From date of randomization until the date of death from any cause, assessed up to 120 months

Study Arms (2)

Immediate surgery

ACTIVE COMPARATOR

Patients undergo excision of a renal mass by partial or radical nephrectomy and will be followed by UISS risk classification.

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

Procedure: Delayed surgery

Interventions

Delayed surgery PROCEDURE

Delayed surgery is performed if cystic mass radiologically upgrades into Bosniak 4 or solid mass in the active surveillance.

Active surveillance

Immediate surgery PROCEDURE

Partial or radical nephrectomy is performed as treatment of Bosniak 3 cystic mass

Immediate surgery

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

MeSH Terms

Conditions

Kidney Diseases, Cystic; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Harry Nisén

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry Nisén, Adj. professor

CONTACT

+35894711; harry.nisen@hus.fi

Juhana Rautiola

CONTACT

+35894711; juhana.rautiola@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 17, 2020
• Study Start: March 15, 2021
• Primary Completion: January 11, 2024
• Study Completion (Estimated): January 11, 2036
• Last Updated: February 17, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication.
• Access Criteria: Requests are reviewed by the steering committee.