Blood sampling of oncology patients treated with monoclonal antibodies
Recruiting
- Conditions
- All malignancies that are treated with intravenous monoclonal antibodies
- Registration Number
- NL-OMON27631
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Age ≥18 years
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Unable to draw blood for study purposes
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To set up a bank of prospectively collected blood samples from patients treated with monoclonal antibodies.
- Secondary Outcome Measures
Name Time Method - To correlate pharmacokinetic (PK) parameters with effectiveness and toxicity of monoclonal antibodies.<br /><br><br>- To determine the influence of immunogenicity on PK.<br /><br><br>- To determine the influence of peripheral blood immune cell characteristics on PK and effectiveness and toxicity of monoclonal antibodies.<br /><br><br>- Explore the characteristics of exosomes before start of treatment, during treatment, and after disease progression.<br /><br><br>- To assess the course of PK and PBMC characteristics shortly after the first treatment cycle, i.e. within 1 week.- To validate an assay that can determine serum concentrations of monoclonal antibodies.<br>