Clinical trial NCT03125707: German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
Official title: German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: BCR-ABL1-Negative Myeloid Neoplasms
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 2172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the diagnosis of a BCR-ABL 1-negative myeloid neoplasm in participating centers

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

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

Primary outcomes:
measure: Treatment decision
timeFrame: 25 years
measure: Response
timeFrame: 25 years
measure: Overall survival
timeFrame: 25 years
measure: Progression-free-survival
timeFrame: 25 years
measure: Duration of response
timeFrame: 25 years
measure: 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.
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Hämatologische Onkologie Praxis Augsburg
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Saarow
country: Germany
facility: Helios Klinikum, Bad Saarow
city: Baden-Baden
country: Germany
facility: Klinikum Mittelbaden
city: Coburg
country: Germany
facility: MVZ Klinikum Coburg
city: Donauwörth
country: Germany
facility: Donauwörth, Onko-Medeor
city: Dresden
country: Germany
facility: Onkologie, BAG, Dresden
city: Erding
country: Germany
facility: Onkologie Erding
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald
city: Göppingen
country: Germany
facility: Alb Fils Kliniken Göppingen
city: Heidelberg
country: Germany
facility: Onkologische Praxis, Heidelberg
city: Heilbronn
country: Germany
facility: Onkologische Schwerpunktpraxis, Heilbronn
city: Herne
country: Germany
facility: Marienhospital Bochum-Herne
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kempten
country: Germany
facility: Klinikum Kempten-Oberallgäu gGmbH
city: Landshut
country: Germany
facility: Landshut VK&K Studien GbR
city: Leer
country: Germany
facility: Leer, Studienzentrum Unter Ems
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Mannheim
country: Germany
facility: Mannheim, Onkologiepraxis
city: Memmingen
country: Germany
facility: Memmingen, Onkologiepraxis
city: Minden
country: Germany
facility: Mühlenkreiskliniken Minden
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwäbisch Gmünd
city: Stuttgart
country: Germany
facility: Diakonie-Klinikum Stuttgart
city: Stuttgart
country: Germany
facility: Stuttgart, MVZ am RBK
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Winnenden
country: Germany
facility: Rems-Murr-Kliniken Winnenden
city: Würzburg
country: Germany
facility: Würzburg / Kitzingen, Gemeinschaftspraxis Dr. Schlag
Study officials:
References: