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

  • STATUS
    Recruiting
  • End date
    Jan 24, 2038
  • participants needed
    2000
  • sponsor
    University of Ulm
Updated on 24 January 2021
Investigator
Frank Stegelmann, MD
Primary Contact
Universit tsklinikum Ulm (9.2 mi away) Contact
+32 other location

Summary

To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 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

Description

To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 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

Details
Condition BCR-ABL1-Negative Myeloid Neoplasms, BCR-ABL1-Negative Myeloid Neoplasms, BCR-ABL1-Negative Myeloid Neoplasms
Treatment Registry study
Clinical Study IdentifierNCT03125707
SponsorUniversity of Ulm
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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 suspected diagnosis of one of the following BCR-ABL1-negative myeloid
neoplasm
Myeloproliferative neoplasm according to WHO 2008
Myeloid neoplasm associated with eosinophilia and abnormalities of PDGFRA, PDGFRB, or FGFR1 according to WHO 2008
Secondary myelofibrosis following ET or PV according to IWG-MRT 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 processing of the individual disease characteristics and course BCR-ABL1-positive chronic myeloid leukemia
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