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Blood sampling of oncology patients treated with monoclonal antibodies


- candidate number28533
- NTR NumberNTR7015
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-feb-2018
- Secondary IDsMEC 16-011 
- Public TitleBlood sampling of oncology patients treated with monoclonal antibodies
- Scientific TitleProspective sampling in intravenously treated oncology patients: monoclonal antibodies
- ACRONYMMULTOMAB
- hypothesisTo set up a bank of prospectively collected blood samples for pharmacokinetic analyses of monoclonal antibodies and immunophenotyping
- Healt Condition(s) or Problem(s) studiedMonoclonal antibodies, Blood withdrawal, Cancer patients
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
Age ≥18 years
Able to understand the written information and able to give informed consent
Planned treatment with (intravenous) monoclonal antibodies for any type of cancer according to standard of care. Monoclonal antibodies include, but are not limited to: cetuximab, nivolumab, ipilimumab, pembrolizumab, bevacizumab, and trastuzumab.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
Unable to draw blood for study purposes
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 5-apr-2016
- planned closingdate1-jan-2026
- Target number of participants1000
- InterventionsNone
- Primary outcomeTo set up a bank of prospectively collected blood samples from patients treated with monoclonal antibodies.
- Secondary outcome- To correlate pharmacokinetic (PK) parameters with effectiveness and toxicity of monoclonal antibodies.
- To determine the influence of immunogenicity on PK.
- To determine the influence of peripheral blood immune cell characteristics on PK and effectiveness and toxicity of monoclonal antibodies.
- Explore the characteristics of exosomes before start of treatment, during treatment, and after disease progression.
- 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.
- TimepointsPrior to every infusion.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Edwin Basak
- CONTACT for SCIENTIFIC QUERIES Edwin Basak
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryTo set up a bank of prospectively collected blood samples for pharmacokinetic analyses of monoclonal antibodies and immunophenotyping
- Main changes (audit trail)
- RECORD6-feb-2018 - 22-feb-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl