pTa G1-2 bladder cancer C67 D41.4
Conditions
Interventions
Group 1: Follow-up of NMIBC-patients with urine-based markers (UroVysion, NMP22) and additionally urinary cytology, ultrasound for detection of recurrence
Group 2: Follow-up of NMIBC-patients (Non-mus
Sponsors
Forschungsstiftung Medizin am Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of marker-detected recurrent and progressive (muscel-invasive) bladder tumours | — |
Secondary
| Measure | Time frame |
|---|---|
| Preventable proportion of cystoscopies due to marker results Frequency of pains and complications (bleeding, inflammation) due to outpatient cystoscopies Frequency and type of treatment in the usual care arm compared to current guidelines of the EAU (European Association of Urology) Cost-benefit-comparison of follow-up | — |
Countries
Germany
Contacts
Public ContactNatalya Benderska
Urologie 24 gGmbH
Outcome results
None listed