NORTH-REG Dwell Time study

Previous studies show that the majority of NMIBC patients experience side effects to BCG and therefore terminate the treatment before completing all planned instillations. This will increase their risk of recurrence and lead to potential cystectomy or progression. 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 and to evaluate whether this can lead to higher adherence to the regimen.

Nordic Principal Investigators: PhD-student Lene Munk and Professor Jørgen Bjerggaard Jensen, Aarhus University Hospital, Denmark

Including countries: Sweden, Norway, Denmark and Iceland

Status: Ongoing

Nordic cystectomy biomarker validation study (NorCys)

The rationale for the study is to collect data of patients undergoing RC for MIBC in Nordic countries in a prospective, multi-institutional and international design. The collected data will be used with the aim of validating existing prediction tools and discover novel tools for 1) prediction of morbidity related to RC, 2) prediction of oncological outcome after RC, and 3) prediction of response to NAC prior to RC. The hypothesis is that with this study we can meet the abovementioned aims and develop a well-documented model for prediction of individual patient outcome regarding RC.

Nordic Principal Investigator: Professor Peter Boström, Turku University Hospital, Finland

Including countries: Finland, Sweden, Norway, Denmark and Iceland

Status: Ongoing

Nordic Bladder Cancer Database Study

NORTH-REG is performing a thorough mapping of all bladder cancer patients from central registers to make a complete overview of patient numbers of each subcategory of patients regarding stage, grade and treatments in order to detect any differences in prognosis between the Nordic countries. Especially, mapping of high risk Non Muscle Invasive Bladder Cancer (NMIBC) will be performed as this patient category traditionally represent the most challenging and controversial clinical decision-making. The objective in a substudy on Danish data is to describe the treatment practice of NMIBC patients treated with or without BCG regarding outcomes, treatment side effects and resource use/costs in clinical practice. In addition to this, a subgroup of patients unresponsive to BCG will be analysed separately.

Nordic Principal Investigator: Professor Jørgen Bjerggaard Jensen, Aarhus University Hospital, Denmark

Including countries: Finland, Sweden, Norway, Denmark and Iceland

En Bloc Transurethral Resection of Non-Muscle Invasive Bladder Cancer

Conventional TURB of NMIBC violates basic oncological principles and compromises pathological examination, as the tumour is fragmented before removal. This may be part of the mechanism causing the high recurrence rate of the disease. En Bloc resection, where the tumour is removed in toto, is supposed to overcome these flaws of conventional TURB. The aim of this multicentre randomised controlled trial is to compare the surgical method of En Bloc resection to conventional TURB in terms of complete removal of tumour, specimen quality, and pathological certainty.

Nordic Principal Investigators: PhD-student Ninna Kjær Nielsen and Professor Jørgen Bjerggaard Jensen, Aarhus University Hospital, Denmark

Including countries: Denmark, Norway, Finland

Status: Ongoing