Less intense follow-up in patients with intermediate-risk non-muscle invasive bladder cancer

ISRCTN	ISRCTN74951762
DOI	https://doi.org/10.1186/ISRCTN74951762
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Skåne University Hospital
Funder	Skånes universitetssjukhus

Submission date: 18/04/2024
Registration date: 29/05/2024
Last edited: 03/09/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Fredrik Liedberg
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
Email	Fredrik.liedberg@med.lu.se

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/02/2029

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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	01/12/2025
Date of final enrolment	01/02/2028

Locations

Countries of recruitment

Sweden

Study participating centre

Skåne University Hospital, Dept. of Urology

Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/09/2025: The date of first enrolment was changed from 01/09/2025 to 01/12/2025.
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.