Condition category
Cancer
Date applied
07/01/2019
Date assigned
18/02/2019
Last edited
18/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
During the last five years knowledge about molecular subtypes in bladder cancer has emerged. This means that bladder cancer is not one disease, but a heterogenous disease entity. The aim of this study is to investigate how molecular subtypes affect prognosis and progression-free survival in bladder cancer.

Who can participate?
Patients with bladder cancer who have undergone transurethral resection of the tumour (TURB)

What does the study involve?
Participants undergo molecular subtyping by means of RNA sequencing from tumour samples. They are followed up for at least two years to assess progression-free survival.

What are the possible benefits and risks of participating?
There are no risks of participating in this study neither are there any obvious benefits as the treatment will not be changed in this study according to the findings of the molecular subtyping.

Where is the study run from?
1. Malmö University Hospital
2. Landskrona Hospital
3. Helsingborg Hospital
4. Ängelholm Hospital
5. Central Hospital Kristianstad
6. Ljungby Hospital
7. Växsjö Hospital
8. Blekinge Hospital
9. Ystad Hospital

When is the study starting and how long is it expected to run for?
January 2017 to December 2024

Who is funding the study?
1. Cancerfonden
2. BioCARE
3. Krapperup fond
4. ALF
5. MAS Cancer

Who is the main contact?
Prof. Fredrik Liedberg

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fredrik Liedberg

ORCID ID

Contact details

Institution of Translational Medicine
Lund University
Section of Urology
Malmö University Hospital
Malmö
221 05
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01/2019

Study information

Scientific title

Bladder cancer molecular subtypes in clinical practice (UROSCANSEQ)

Acronym

UROSCANSEQ

Study hypothesis

Application of molecular subtypes in clinical practice is necessary to gain knowledge about molecular classification.

Ethics approval

Regionala Etikprövningsnämnden i Lund (the Regional Ethical Review Board in Lund), Box 133, 221 00 Lund, Tel: +46 (0)46 2224180, Email: registrator@epn.lu.se, 10/03/2017, ref: 2012/74 and 2017/34

Study design

Multicentre prospective cohort-study.

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format

Condition

Urothelial carcinoma of the urinary bladder

Intervention

RNA-sequencing of bladder tumours and molecular subtyping and assessment of molecular grade. Patients will be followed up for at least two years after inclusion to assess progression-free survival.

Intervention type

Genetic

Phase

Drug names

Primary outcome measure

Molecular subtype and grade. The timepoints for assessment of the primary and secondary outcomes will be standardised according to the Swedish national guidelines for bladder cancer regarding recommended follow-up intervals. For the study population this means control with cystoscopy every third month for two years, every sixth month the following three years and then annually with a lifelong follow up.

Secondary outcome measures

Progression-free survival. The timepoints for assessment of the primary and secondary outcomes will be standardised according to the Swedish national guidelines for bladder cancer regarding recommended follow-up intervals. For the study population this means control with cystoscopy every third month for two years, every sixth month the following three years and then annually with a lifelong follow up.

Overall trial start date

01/01/2017

Overall trial end date

31/12/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Bladder cancer subjected to transurethral resection of the tumour (TURB)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20,000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

26/11/2018

Recruitment end date

31/12/2024

Locations

Countries of recruitment

Sweden

Trial participating centre

Malmö University Hospital
Dept. of Urology, Jan Waldenströmsgata 5
Malmö
205 02
Sweden

Trial participating centre

Landskrona Hospital
Region Skåne Department of Urology Vattenverksallén
Landskrona
261 36
Sweden

Trial participating centre

Helsingborg Hospital
Department of urology Charlotte Yhlens gata 10
Helsingborg
251 87
Sweden

Trial participating centre

Ängelholm Hospital
Department of Urology Västersjögatan 12
Ängelholm
262 53
Sweden

Trial participating centre

Central Hospital Kristianstad
Division of Urology J A Hedlunds väg 5
Kristianstad
291 33
Sweden

Trial participating centre

Ljungby Hospital
Division of urology Kyrkogatan 2
Ljungby
341 35
Sweden

Trial participating centre

Växsjö Hospital
Division of Urology 352 34 Växjö
Växjö
352 34
Sweden

Trial participating centre

Blekinge Hospital
Division of Urology Lasarettsvägen
Karlskrona
371 41
Sweden

Trial participating centre

Ystad Hospital
Division of Urology Kristianstadsvägen 3
Ystad
271 33
Sweden

Sponsor information

Organisation

Skåne University Hospital

Sponsor details

Department of Urology
Jan Waldenströmsgata 7
Malmö
-
Sweden
+46 (0)40 33 10 00
fredrik.liedberg@med.lu.se

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Cancerfonden

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

BioCARE

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Krapperup fond

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ALF

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

MAS Cancer

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol in Swedish will not be available online. The study will be published in a high-impact peer reviewed journal one year after study closure.

IPD sharing statement
The datasets generated during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2025

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes