Identification of muscle-invasive bladder cancer patients who will not benefit from neoadjuvant chemotherapy using circulating tumor cells.
Recruiting
- Conditions
- muscle-invasive bladder cancer, circulating tumor cells, neoadjuvant chemotherapyspierinvasieve blaaskanker, circulerende tumorcellen, neoadjuvante chemotherapie
- Registration Number
- NL-OMON23413
- Lead Sponsor
- Erasmus MC
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 260
Inclusion Criteria
Histopathologically confirmed muscle-invasive urothelial carcinoma of the bladder.
- Clinical stage T2-T4a N0-N1 bladder cancer.
Exclusion Criteria
- Muscle-invasive bladder cancer other than urothelial carcinoma (adenocarcinoma, squamous cell carcinoma, small cell carcinoma, neuro-endocrine tumor).
- History of other malignant disease with a tumor-free interval of less than 5 years.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint for this study will be the 2-year overall survival rate in nonmetastatic MIBC patients without<br>detectable CTCs treated with radical local treatment without prior neoadjuvant chemotherapy.
- Secondary Outcome Measures
Name Time Method Secondary endpoints include 2-year overall survival in the remaining patients and cancer-specific survival, relapse-free survival, local relapse-free survival and metastasis-free survival for all the patients. In addition, the expression pattern of the 20-gene panel is also a secondary endpoint.