German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Registry study.
- Who it may be relevant to
- Registry conditions: BCR-ABL1-Negative Myeloid Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Other Registry study
Primary outcome measures
- Treatment decision [Time frame: 25 years]
- Response [Time frame: 25 years]
- Overall survival [Time frame: 25 years]
- Progression-free-survival [Time frame: 25 years]
- Duration of response [Time frame: 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. [Time frame: 25 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 30 centers
- Hämatologische Onkologie Praxis Augsburg — Augsburg
- Klinikum Augsburg — Augsburg
- Helios Klinikum, Bad Saarow — Bad Saarow
- Klinikum Mittelbaden — Baden-Baden
- MVZ Klinikum Coburg — Coburg
- Donauwörth, Onko-Medeor — Donauwörth
- Onkologie, BAG, Dresden — Dresden
- Onkologie Erding — Erding
- … and 22 more centers
Identifiers
NCT: NCT03125707 · MPN Registry - Ulm