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The purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in Germany.
RUBIN is a national, observational, prospective, longitudinal, multicenter registry platform with the purpose to record information on the antineoplastic treatment of hematological malignancies in Germany.
It will identify common therapeutic sequences and changes in the treatment of the disease, and will analyse the impact of novel treatments on the outcome of patients in routine care. Unmet needs and areas with the potential for improvement in routine care are to be identified.
At inclusion, data in patient characteristics, comorbidities, clinical characteristics and previous treatments, if applicable, are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and clinical outcome are documented.
Health-realted quality of life in patients with hematological malignancies will be evaluated for up to one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Patients with CLL receiving systemic treatment (physician's choice) |
| |
| Diffuse Large B-cell Lymphoma (DLBCL) | Patients with DLBCL receiving systemic treatment (physician's choice) |
| |
| Follicular Lymphoma (FL) | Patients with FL receiving systemic treatment (physician's choice) |
| |
| Mantle Cell Lymphoma (MCL) | Patients with MCL receiving systemic treatment (physician's choice) |
| |
| Marginal Zone Lymphoma (MZL) | Patients with MZL receiving systemic treatment (physician's choice) |
| |
| Waldenström's macroglobulinemia (WM) | Patients with WM receiving systemic treatment (physician's choice) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine care as per site standard. | Other | Physician's choice according to patient's needs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Course of treatment (treatment reality) | Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response | Documentation of response rates per line of treatment. | 5 years |
| Progression-free survival | Documentation of progression-free survival per line of treatment. |
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Inclusion Criteria:
Age ≥ 18 years
Confirmed diagnosis of the respective NHL
If patient is alive: signed written informed consent
Exclusion Criteria:
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Adult patients with hematologic malignancies requiring systemic treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martina Jänicke, Dr. | Contact | +4976115242 | 0 | rubin@iomedico.com |
| Name | Affiliation | Role |
|---|---|---|
| Rainer Claus, Prof. Dr. | Universitätsklinikum Augsburg, Germany | Study Chair |
| Tobias Dechow | Studienzentrum Onkologie Ravensburg, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis für Interdisziplinäre Hämatologie und Onkologie | Recruiting | Freiburg im Breisgau | Germany |
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|
| 5 years |
| Overall survival | Documentation of overall survival time. | 5 years |
| Health-related quality of life (Patient-reported outcome) | EORTC QLQ-C30 core questionnaire | 1 year |
| Disease-specific quality of life (Patient-reported outcome, patients with CLL) | EORTC QLQ-CLL17 | 1 year |
| Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL) | EORTC QLQ-NHL-LG20 | 1 year |
| Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL) | EORTC QLQ-NHL-HG29 | 1 year |
| Paul Graf La Rosée, Prof. Dr. |
| Schwarzwald-Baar Klinikum, Germany |
| Study Chair |
| Jens Kisro, Dr. | Lübecker Onkologische Schwerpunktpraxis, Germany | Study Chair |
| Patrick Marschner, Dr. | Praxis für Interdisziplinäre Hämatologie und Onkologie, Freiburg, Germany | Study Chair |
| Ingo Tamm, PD Dr. | Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, Germany | Study Chair |
| Robert Zeiser, Prof. Dr. | Universitätsklinikum Freiburg, Germany | Study Chair |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008258 | Waldenstrom Macroglobulinemia |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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