Prognostic value of molecular subtypes in bladder cancer
| ISRCTN | ISRCTN15459149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15459149 |
| Secondary identifying numbers | 01/2019 |
- Submission date
- 07/01/2019
- Registration date
- 18/02/2019
- Last edited
- 19/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
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 June 2026
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
Contact information
Scientific
Institution of Translational Medicine, Lund University
Section of Urology
Malmö University Hospital
Malmö
221 05
Sweden
Study information
| Study design | Multicentre prospective cohort-study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format |
| Scientific title | Bladder cancer molecular subtypes in clinical practice (UROSCANSEQ) |
| Study acronym | UROSCANSEQ |
| Study objectives | Application of molecular subtypes in clinical practice is necessary to gain knowledge about molecular classification. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2017 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20,000 |
| Key inclusion criteria | Bladder cancer subjected to transurethral resection of the tumour (TURB) |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 26/11/2018 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Malmö
205 02
Sweden
Department of Urology
Vattenverksallén
Landskrona
261 36
Sweden
Charlotte Yhlens gata 10
Helsingborg
251 87
Sweden
Västersjögatan 12
Ängelholm
262 53
Sweden
J A Hedlunds väg 5
Kristianstad
291 33
Sweden
Kyrkogatan 2
Ljungby
341 35
Sweden
352 34 Växjö
Växjö
352 34
Sweden
Lasarettsvägen
Karlskrona
371 41
Sweden
Kristianstadsvägen 3
Ystad
271 33
Sweden
Sponsor information
Not defined
Department of Urology
Jan Waldenströmsgata 7
Malmö
-
Sweden
| Phone | +46 (0)40 33 10 00 |
|---|---|
| fredrik.liedberg@med.lu.se | |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/05/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated during this study will be included in the subsequent results publication. |
Editorial Notes
19/12/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2024 to 30/06/2026.
2. The overall study end date was changed from 31/12/2024 to 30/06/2026.
3. The intention to publish date was changed from 31/12/2025 to 31/05/2027.
07/11/2023: The contact confirmed the record is up to date.
