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

BCR-ABL1-Negative Myeloid Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03125707
• Other study ID #: MPN Registry - Ulm
• Status: Recruiting
• Start date: May 2013
• Est. completion date: September 2045

Study information

• Verified date: May 2023
• Source: University of Ulm
• Contact: Frank Stegelmann, Dr.
• Phone: +4973150045521
• Email: frank.stegelmann[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2172
• Est. completion date: September 2045
• Est. primary completion date: September 2045
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BCR-ABL1-Negative Myeloid Neoplasms
• Neoplasms

Intervention

Other:
• Registry study

Locations

Country	Name	City	State
Germany	Hämatologische Onkologie Praxis Augsburg	Augsburg
Germany	Klinikum Augsburg	Augsburg
Germany	Helios Klinikum, Bad Saarow	Bad Saarow
Germany	Klinikum Mittelbaden	Baden-Baden
Germany	MVZ Klinikum Coburg	Coburg
Germany	Donauwörth, Onko-Medeor	Donauwörth
Germany	Onkologie, BAG, Dresden	Dresden
Germany	Onkologie Erding	Erding
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Alb Fils Kliniken Göppingen	Göppingen
Germany	Universitätsklinikum Greifswald	Greifswald
Germany	Onkologische Praxis, Heidelberg	Heidelberg
Germany	Onkologische Schwerpunktpraxis, Heilbronn	Heilbronn
Germany	Marienhospital Bochum-Herne	Herne
Germany	Universitätsklinikum Jena	Jena
Germany	Klinikum Kempten-Oberallgäu gGmbH	Kempten
Germany	Landshut VK&K Studien GbR	Landshut
Germany	Leer, Studienzentrum Unter Ems	Leer
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Mannheim, Onkologiepraxis	Mannheim
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Memmingen, Onkologiepraxis	Memmingen
Germany	Mühlenkreiskliniken Minden	Minden
Germany	Stauferklinikum Schwäbisch Gmünd	Mutlangen
Germany	Diakonie-Klinikum Stuttgart	Stuttgart
Germany	Stuttgart, MVZ am RBK	Stuttgart
Germany	Universitätsklinikum Ulm	Ulm
Germany	Rems-Murr-Kliniken Winnenden	Winnenden
Germany	Würzburg / Kitzingen, Gemeinschaftspraxis Dr. Schlag	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment decision	Treatment decision (watch and wait, standard, investigational)	25 years
Primary	Response	Response of treatment	25 years
Primary	Overall survival	Survival over the whole study duration	25 years
Primary	Progression-free-survival	Survival without any progression	25 years
Primary	Duration of response	Duration of response over the whole study duration	25 years
Primary	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.	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