Marker-based follow-up of patients with non muscle-invasive low/intermediate risk bladder cancer

Phase 3

• Conditions: pTa G1-2 bladder cancer; C67; D41.4; Malignant neoplasm of bladder; Bladder

• Registration Number: DRKS00010069
• Lead Sponsor: Forschungsstiftung Medizin am Universitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-22
• Study Completion: 2022-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Completely resected primary or recurrent bladder cancer low/intermediate risk NMIBC pTa G1-2 with progression risk <5% within 3 years of follow-up, based on EORTC-risk-tables (Sylvester et al. 2006; http://www.eortc.be/tools/bladdercalculator); ECOG-status 0-2 (ambulatory, capable of self-care)

Exclusion Criteria

Adjuvant BCG-therapy;
Concomitant bladder carcinoma in situ;
Tumour size >3 cm;
Pregnancy;
Participation in another oncological study;
Other cancers (except of cutaneous squamous or basal cell carcinoma) within the last 5 years;
Dialysis-dependent renal insufficiency

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of marker-detected recurrent and progressive (muscel-invasive) bladder tumours

Secondary Outcome Measures

Name	Time	Method
Preventable proportion of cystoscopies due to marker results<br><br>Frequency of pains and complications (bleeding, inflammation) due to outpatient cystoscopies<br><br>Frequency and type of treatment in the usual care arm compared to current guidelines of the EAU (European Association of Urology)<br><br>Cost-benefit-comparison of follow-up<br>