Circulating tumor DNA in urothelial cancer.
Recruiting
- Conditions
- rothelial cancer -Blaaskanker
- Registration Number
- NL-OMON24518
- Lead Sponsor
- The Netherlands Cancer Institute- Antoni van Leeuwenhoek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Indication for systemic treatment with anti-cancer agents in patients with urothelial cancer.
- WHO performance status 0-2
Exclusion Criteria
- Coleection of tissue from a metastatic or primary lesion is not possible.
- Pure non-urothelial carcinoma (SCC/Adenocarcinoma) of the bladder or urinary tract
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To explore the longitudinal kinetics of tumor mutations in the urine and plasma of bladder cancer patients receicing systemic therapy fo locally advanced cancer or metastatic disease.
- Secondary Outcome Measures
Name Time Method - To determine the detectability rate and range in levels ctDNA in plasma before start of treatment<br /> <br>- To explore the correlation of levels of ctDNA in plasma with tumor burden <br /><br>- To explore the correlation between radiological response and urine ctDNA and plasma ctDNA kinetics during and following treatment<br /><br>- To explore the prognostic value of urine ctDNA and plasma ctDNA for treatment outcome (progression free survival) of neoadjuvant chemotherapy for bladder cancer<br /><br>- To explore the range and frequency of mutations found in ctDNA, urine ctDNA and tumor samples in bladder cancer.<br /><br> - Build a biobank of longitudinally collected bladder cancer samples for translational research.