Studieoverzicht - 2017-02 PERIDENO
| Principal Investigator(s) | Dr. J.R. Kroep (Leids Universitair Medisch Centrum) | |||
| Study manager | Drs. A.F. de Groot, LUMC (studiecoördinator) T. Volker, MSc, BOOG Study Center (Project medewerker) Dr. A. E. van Leeuwen-Stok, BOOG Study Center (Clinical Study Manager) |
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| Central datamanagement and randomization | Datacenter Heelkunde, LUMC, Postbus 9600 2300 RC Leiden, The Netherlands ClinicalResearchCenter@lumc.nl | 071-5263500 |
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| Monitoring | Clinical Research Center Lumc 071-5263500 |
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| Local datamanagement | IKNL or Site | |||
| Funding | Amgen | |||
| Extra | Please note that the PERIDENO study will not be continued. Coordinating investigator/project leader: A.F. de Groot (Leids Universitair Medisch Centrum) | |||
Design:
Objectives:
Primary objective:
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Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC cell) numbers and function between the baseline biopsy and the surgical specimen.
Secondary objectives:
- PBMC before start treatment, at day of surgery and 7 days after last chemotherapy administration:
- Determine the shift in T-cell (activated T effector cells and regulatory T cells) levels and function in PBMC samples.
- Determine the change in mature and immature myeloid cells (M1, M2, MDSC, DC).
- Determine the shift in myeloid cell function (IL-10 and IL-12 production after LPS or anti-CD40 triggering).
- Determine the change in stimulation capacity APCs (MLR + cytokine production after restimulation).
- Serum before start treatment, at day of surgery and 7 days after last chemotherapy administration):
- Determine the change in RANKL, OPG by ELISA; TNF-alpha, IL-1-beta, IL-6, IL-7, IL-10, IL-15, IL-12, IFN gamma by luminex.
- Tumor
- Correlate tumor (biopsy and resection material), serum and PBMC immunologic parameters.
- Toxicity according to NCI CTCAE v4.03.
- Determine the descriptive difference in disease free survival (DFS) at 3 year based on immune response.
Endpoints:
Main eligibility criteria:
Documents (public):
Protocol synopsis
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