BCR-ABL1-Negative Myeloid Neoplasms
Conditions
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
Interventions
OTHERRegistry study
Sponsors
University of Ulm
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment decision | 25 years | Treatment decision (watch and wait, standard, investigational) |
| Response | 25 years | Response of treatment |
| Overall survival | 25 years | Survival over the whole study duration |
| Progression-free-survival | 25 years | Survival without any progression |
| Duration of response | 25 years | Duration of response 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. |
Countries
Germany
Contacts
Primary ContactFrank Stegelmann, Dr.
Outcome results
None listed