Less intense follow-up in patients with intermediate-risk non-muscle invasive bladder cancer
| ISRCTN | ISRCTN74951762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74951762 |
- Submission date
- 18/04/2024
- Registration date
- 29/05/2024
- Last edited
- 06/02/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
To prospectively investigate if a less intense follow-up schedule during the first 24 months for patients with primary or recurrent intermediate risk non-muscle invasive bladder cancer (NMIBC) after a negative first cystoscopy after transurethral resection of bladder (TURB) and adjuvant instillations have non-inferior oncologic outcomes defined as a proportion of patients with maximal diameter above 12 mm at recurrence. Additionally, the study aims to investigate if point-of-care use of urine tests in the de-escalated intervention arm is of value in this context.
Who can participate?
Patients with primary or recurrent intermediate-risk NMIBC
What does the study involve?
The study tests if it is safe to follow patients with NMIBC with less frequent endoscopic controls where we patients are allocated to a less intense follow-up protocol compared to the current standard which is every six months.
What are the possible benefits and risks of participating?
The benefit of participating is a 50% chance of having two instead of four cystoscopies during 2 years of observation of the disease.
The risks are related to slightly larger tumours at detection in the intervention group with less intense follow-up, although this will not affect the disease course over time.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
December 2023 to February 2029
Who is funding the study?
Skåne University Hospital (Sweden)
Who is the main contact?
Fredrik Liedberg, fredrik.liedberg@med.lu.se
Contact information
Public, Scientific, Principal Investigator
Skåne University Hospital, Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden
 ORCID ID |
0000-0001-8193-0370 |
|---|---|
| Phone | +46-40-331000 |
| Fredrik.liedberg@med.lu.se |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | De-eScalated Follow-up in Intermediate-Risk NMIBC Gain Resources – a prospective ranDomized trial |
| Study acronym | SIGRID |
| Study objectives | Less intense follow-up is non-inferior to the current guideline recommendations. |
| Ethics approval(s) |
Approved 13/03/2024, The Swedish Ethical Review Authority (Box 2110, Uppsala, SE-75002, Sweden; +46-10-475 08 00; registrator@etikprovning.se), ref: Dnr 2024-00076-01 |
| Health condition(s) or problem(s) studied | Bladder cancer |
| Intervention | The study involves patients with intermediate-risk non-muscle invasive bladder cancer with normal first follow-up cystoscopy. The intervention is de-escalated follow-up, to decrease the burden of follow-up for patients and healthcare. Randomisation will be performed in RedCap. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The proportion of patients with a recurrent tumour above 12 mm measured using endoscopy in mm in relation biopsy forceps at 6, 12, 18 and 24 months |
| Secondary outcome measures | 1. Health-related quality of life (HRQoL) measured using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)-non-muscle-invasive bladder cancer 24 (NMIBC24) at 12 and 24 months 2. Incremental cost-effectiveness ratio (ICER) = total cost divided by gain in quality-adjusted life years (QALYs) for the less intense follow-up schedule measured using the EQ-5D-5L at 12 and 24 months 3. Proportion positive urine test at least one visit before recurrence measured using a tumour test applied on urine samples at 6, 12, 18 and 24 months 4. Rate of recurrence measured in medical record using the proportion with recurrent disease at 6, 12, 18 and 24 months 5. Rate of progression measured using a pathological assessment of recurrent tumours at 6, 12, 18 and 24 months 6. Number of cystoscopies examinations recorded in medical notes at 24 months |
| Overall study start date | 02/12/2023 |
| Completion date | 01/02/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | Primary or recurrent intermediate risk NMIBC |
| Key exclusion criteria | 1. Undergoing treatment for any other active malignancy 2. Previous pelvic radiotherapy 3. Pregnancy |
| Date of first enrolment | 01/09/2025 |
| Date of final enrolment | 01/02/2028 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Malmö
SE-205 02
Sweden
Sponsor information
Hospital/treatment centre
Department of Urology, Jan Waldenströms gata 5
Malmö
SE-20502
Sweden
| Phone | +46 (0)40 33 10 00 |
|---|---|
| Jenny.Hellfalk@skane.se | |
| Website | https://vard.skane.se/skanes-universitetssjukhus-sus/ |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
University/education
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Skåne University Hospital, SUS
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/02/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Editorial Notes
06/02/2025: The recruitment start date was changed from 01/02/2025 to 01/09/2025.
19/04/2024: Study's existence confirmed by the Swedish Ethical Review Authority.
