German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)

Study Overview
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Brief Summary
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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
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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

Official Title
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German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)

Conditions
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BCR-ABL1-Negative Myeloid Neoplasms

Intervention / Treatment
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* Other: Registry study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Severe neurological or psychiatric disorder interfering with ability to give an informed consent No consent for registration, storage and handling of the personal data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Registry study|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment decision | Treatment decision (watch and wait, standard, investigational) | 25 years | 
| Response | Response of treatment | 25 years | 
| Overall survival | Survival over the whole study duration | 25 years | 
| Progression-free-survival | Survival without any progression | 25 years | 
| Duration of response | Duration of response over the whole study duration | 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. | 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 |