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
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