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

De-eScalated Follow-up in Intermediate-Risk NMIBC Gain Resources – a prospective ranDomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74951762

Enrollment

400

Registered

2024-05-29

Start date

2026-10-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer Cancer

Interventions

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 foll

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Primary or recurrent intermediate risk NMIBC

Exclusion criteria

Exclusion criteria: 1. Undergoing treatment for any other active malignancy 2. Previous pelvic radiotherapy 3. Pregnancy

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Sweden

Contacts

Public ContactFredrik Liedberg

Fredrik.liedberg@med.lu.se+46-40-331000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026