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Observational prospective study. Patients with DLBCL and HGBCL will be enrolled in the study to collect samples for developing a blood based assay allowing biomarker driven treatment in the future.
The rationale of this study is that, due to the lack of successful salvage options, first-line treatment outcome needs to be improved. To make this possible, a crucial condition is optimal identification of patients that will not be cured on R-CHOP. The aim of this protocol is to develop new tools to monitor treatment response and disease outcome. Molecular monitoring of treatment response through liquid biopsies (LB) is such a promising new tool.
The primary objective is to collect liquid biopsy samples of patients with newly diagnosed DLBCL/HGBCL to develop a blood based assay allowing biomarker driven treatment in the future.
The secondary objectives are to collect clinical data and pre-treatment tissue samples (for determining molecular profiles) to allow for correlation to the blood based assay.
This study is designed for patients with newly diagnosed DLBCL and HGBCL ≥ 18 yr.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue material | For genomic analysis and clinical outcome data | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with limited stage I, II disease planned to receive 3 cycles of R-CHOP + radiotherapy, or 4 x R-CHOP+ 2R
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Patients who meet the eligibility criteria
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| Name | Affiliation | Role |
|---|---|---|
| M.E.D. Chamuleau, MD, PhD | VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NL-Den Bosch-JBZ | 's-Hertogenbosch | Netherlands | ||||
| NL-Alkmaar-NWZ |
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| Alkmaar |
| Netherlands |
| NL-Almelo-ZGTALMELO | Almelo | Netherlands |
| NL-Almere-FLEVOZIEKENHUIS | Almere Stad | Netherlands |
| NL-Amersfoort-MEANDERMC | Amersfoort | Netherlands |
| NL-Amstelveen-AMSTELLAND | Amstelveen | Netherlands |
| NL-Amsterdam-AMC | Amsterdam | Netherlands |
| NL-Amsterdam-OLVG | Amsterdam | Netherlands |
| NL-Amsterdam-VUMC | Amsterdam | Netherlands |
| NL-Arnhem-RIJNSTATE | Arnhem | Netherlands |
| NL-Assen-WZA | Assen | Netherlands |
| NL-Beverwijk-RKZ | Beverwijk | Netherlands |
| NL-Breda-AMPHIA | Breda | Netherlands |
| NL-Capelle a/d IJssel-YSL | Capelle aan den IJssel | Netherlands |
| NL-Delft-RDGG | Delft | Netherlands |
| NL-Deventer-DZ | Deventer | Netherlands |
| NL-Dirksland-VANWEELBETHESDA | Dirksland | Netherlands |
| NL-Doetinchem-SLINGELAND | Doetinchem | Netherlands |
| NL-Dordrecht-ASZ | Dordrecht | Netherlands |
| NL-Ede-ZGV | Ede | Netherlands |
| NL-Eindhoven-CATHARINA | Eindhoven | Netherlands |
| NL-Eindhoven-MAXIMAMC | Eindhoven | Netherlands |
| NL-Emmen-SCHEPER | Emmen | Netherlands |
| NL-Enschede-MST | Enschede | Netherlands |
| NL-Geldrop-STANNA | Geldrop | Netherlands |
| NL-Goes-ADRZ | Goes | Netherlands |
| NL-Gorinchem-BEATRIX | Gorinchem | Netherlands |
| NL-Gouda-GROENEHART | Gouda | Netherlands |
| NL-Groningen-UMCG | Groningen | Netherlands |
| NL-Hardenberg-SAXENBURGH | Hardenberg | Netherlands |
| NL-Harderwijk-STJANSDALHARDERWIJK | Harderwijk | Netherlands |
| NL-Heerenveen-TJONGERSCHANS | Heerenveen | Netherlands |
| NL-Helmond-ELKERLIEK | Helmond | Netherlands |
| NL-Hoofddorp-SPAARNEGASTHUIS | Hoofddorp | Netherlands |
| NL-Hoorn-DIJKLANDERHOORN | Hoorn | Netherlands |
| NL-Leeuwarden-MCL | Leeuwarden | Netherlands |
| NL-Leiden-LUMC | Leiden | Netherlands |
| NL-Maastricht-MUMC | Maastricht | Netherlands |
| NL-Nieuwegein-ANTONIUS | Nieuwegein | Netherlands |
| NL-Nijmegen-CWZ | Nijmegen | Netherlands |
| NL-Roermond-LZR | Roermond | Netherlands |
| NL-Roosendaal-BRAVIS | Roosendaal | Netherlands |
| NL-Rotterdam-ERASMUSMC | Rotterdam | Netherlands |
| NL-Rotterdam-IKAZIA | Rotterdam | Netherlands |
| NL-Rotterdam-MAASSTADZIEKENHUIS | Rotterdam | Netherlands |
| NL-Rotterdam-SFG | Rotterdam | Netherlands |
| NL-Sneek-ANTONIUSSNEEK | Sneek | Netherlands |
| NL-Spijkenisse-SPIJKENISSEMC | Spijkenisse | Netherlands |
| NL-Terneuzen-ZORGSAAM | Terneuzen | Netherlands |
| NL-Den Haag-HAGA | The Hague | Netherlands |
| NL-Den Haag-HMCWESTEINDE | The Hague | Netherlands |
| NL-Tiel-RIVIERENLAND | Tiel | Netherlands |
| NL-Tilburg-ETZ | Tilburg | Netherlands |
| NL-Uden-BERNHOVEN | Uden | Netherlands |
| NL-Utrecht-DIAKONESSENUTRECHT | Utrecht | Netherlands |
| NL-Utrecht-UMCUTRECHT | Utrecht | Netherlands |
| NL-Venlo-VIECURI | Venlo | Netherlands |
| NL-Winterswijk-SKBWINTERSWIJK | Winterswijk | Netherlands |
| NL-Zutphen-GELREZUTPHEN | Zutphen | Netherlands |
| NL-Zwolle-ISALA | Zwolle | Netherlands |