German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
ConditionBCR-ABL1-Negative Myeloid Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Ulm
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Severe neurological or psychiatric disorder interfering with ability to give an informed consent
No consent for registration, storage and handling of the personal data
Trial population
Patients with the diagnosis of a BCR-ABL 1-negative myeloid neoplasm in participating centers
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Registry study
Other intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Treatment decision
Treatment decision (watch and wait, standard, investigational)
Time frame
25 years2
Response
Response of treatment
Time frame
25 years3
Overall survival
Survival over the whole study duration
Time frame
25 years4
Progression-free-survival
Survival without any progression
Time frame
25 yearsSponsors and contacts
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Source ClinicalTrials.gov