NCT04701151

NORTH-REG Dwell-Time Study

Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Jørgen Bjerggaard Jensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations. The study will include patients from Denmark, Iceland, Norway and Sweden.

Detailed description

Approximately 8,000 patients are diagnosed with bladder cancer (BC) in the Nordic countries every year. The majority of BC patients are diagnosed with non-muscle invasive bladder cancer (NMIBC). The majority of NMIBC are treated with Bacillus Calmette-Guérin vaccine (BCG) as adjuvant treatment but for carcinoma in situ it is the primary treatment. BCG is known to give a lot of side effects both local and systemic, the severity of these can lead to premature termination of the treatment. The object of this PhD project is to investigate if reduced dwell time, the time the BCG is in the bladder, will decrease the severity of side effects due to BCG instillations. This will be investigated in a Nordic setting and the project will be done as a two-armed randomized clinical trial. By decreasing the severity of side effects, we hypothesize the number of patients completing all planned instillations will increase and thereby decrease the risk of the BC evolving into a more aggressive type.

Conditions

• Side Effect of Drug

Interventions

Type	Name	Description
DRUG	Bacillus Calmette Guerin	The same dose of the drug will be given in both arms but the dwell-time will be adjusted for the subjects in the intervention arm according to the grading of side effects given by the study algorithm.

Timeline

• Start date: 2021-02-03
• Primary completion: 2026-12-01
• Completion: 2030-12-01
• First posted: 2021-01-08
• Last updated: 2026-03-03

Locations

11 sites across 3 countries: Denmark, Iceland, Sweden