German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
- Conditions
- BCR-ABL1-Negative Myeloid Neoplasms
- Registration Number
- NCT03125707
- Lead Sponsor
- University of Ulm
- Brief Summary
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers
To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)
To perform morphologic and genetic analyses
To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables
To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
To assess quality of life
- Detailed Description
To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers
To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)
To perform morphologic and genetic analyses
To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables
To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
To assess quality of life
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2172
Both female and male patients meeting the mentioned inclusion criteria will be included in this registry, because the risk to get a myeloid neoplasm does not depend on a patient's gender. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the registry:
- Patients with BCR-ABL 1-myeloid neoplasia according to WHO classification or IWG MRI criteria
- Age ≥ 18 years. There is no upper age limit.
- Signed written informed consent.
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- No consent for registration, storage and handling of the personal data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival 25 years Survival over the whole study duration
Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics. 25 years Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.
Treatment decision 25 years Treatment decision (watch and wait, standard, investigational)
Response 25 years Response of treatment
Duration of response 25 years Duration of response over the whole study duration
Progression-free-survival 25 years Survival without any progression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Klinikum Augsburg
🇩🇪Augsburg, Germany
Hämatologische Onkologie Praxis Augsburg
🇩🇪Augsburg, Germany
Klinikum Mittelbaden
🇩🇪Baden-Baden, Germany
Helios Klinikum, Bad Saarow
🇩🇪Bad Saarow, Germany
Donauwörth, Onko-Medeor
🇩🇪Donauwörth, Germany
MVZ Klinikum Coburg
🇩🇪Coburg, Germany
Onkologie, BAG, Dresden
🇩🇪Dresden, Germany
Onkologie Erding
🇩🇪Erding, Germany
Onkologische Praxis, Heidelberg
🇩🇪Heidelberg, Germany
Alb Fils Kliniken Göppingen
🇩🇪Göppingen, Germany
Marienhospital Bochum-Herne
🇩🇪Herne, Germany
Universitätsklinikum Greifswald
🇩🇪Greifswald, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Klinikum Kempten-Oberallgäu gGmbH
🇩🇪Kempten, Germany
Onkologische Schwerpunktpraxis, Heilbronn
🇩🇪Heilbronn, Germany
Landshut VK&K Studien GbR
🇩🇪Landshut, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Mühlenkreiskliniken Minden
🇩🇪Minden, Germany
Leer, Studienzentrum Unter Ems
🇩🇪Leer, Germany
Mannheim, Onkologiepraxis
🇩🇪Mannheim, Germany
Memmingen, Onkologiepraxis
🇩🇪Memmingen, Germany
Diakonie-Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Stuttgart, MVZ am RBK
🇩🇪Stuttgart, Germany
Stauferklinikum Schwäbisch Gmünd
🇩🇪Mutlangen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Rems-Murr-Kliniken Winnenden
🇩🇪Winnenden, Germany
Würzburg / Kitzingen, Gemeinschaftspraxis Dr. Schlag
🇩🇪Würzburg, Germany