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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| Wuerzburg University Hospital | OTHER |
| University Hospital Ulm | OTHER |
| University of Leipzig |
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The trial aims at the construction and validation of an accurate, affordable and simple prognostic tool to be used in everyday clinical practice, which allows the early and reliable identification of DLBCL patients who have a very high risk of treatment failure following R-CHOP/-like first-line therapy.
Observational study of 500 recruited and 300 evaluable patients with de novo large cell B Cell lymphoma, age 18-80. Standard guideline recommended treatment by treating physicians discretion. Collection of clinical data, PET-CT data, liquid biopsy, WGSequencing to determine optimal prognostic factors to surpass prediction offered by current IPI.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS-2) with 95% confidence intervals | PFS is defined as the time from the day of inclusion into the observation trial through one of the following events, whichever comes first:
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from the day of inclusion into the observation trial to death due to any cause; patients without event will be censored at the last date known to be alive. | 5 years |
| Event-free survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with initial diagnosis of DLBCL qualified for a treatment with R-CHOP/ R-CHOP-like regime
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna-Carina Hund | Contact | +495513961041 | anna-carina.hund@med.uni-goettingen.de | |
| Gerald Wulf | Contact | +495513962050 | gerald.wulf@med.uni-goettingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Lorenz Trümper | PI of the study | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin Göttingen | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
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| OTHER |
| University Hospital Regensburg | OTHER |
| University Hospital Freiburg | OTHER |
| Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) | OTHER |
| University of Kiel | OTHER |
| University Hospital, Essen | OTHER |
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Peripheral Blood Leucocytes Liquid Biopsy Tumor paraffin embedded biopsy
Event-free survival (EFS) is defined as the time from the day of inclusion into the observation trial through one of the following events, whichever comes first:
|
| 5 years |
| Response rates | overall response to treatment | 2 years |
| Safety and toxicity | treatment side effects | 5 years |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |