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

NCT03125707 | Recruiting

• 1 other identifier: MPN Registry - Ulm
• Study Type: observational
• Target: 2,172
• Locations: 1 country
• Sites: 30

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

Conditions

BCR-ABL1-Negative Myeloid Neoplasms

Outcome Measures

Primary Outcomes (6)

• Treatment decision

  Treatment decision (watch and wait, standard, investigational)

  25 years

• Response

  Response of treatment

  25 years

• Overall survival

  Survival over the whole study duration

  25 years

• Progression-free-survival

  Survival without any progression

  25 years

• Duration of response

  Duration of response over the whole study duration

  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.

  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

Interventions

Registry study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of a BCR-ABL 1-negative myeloid neoplasm in participating centers

You may qualify if:

• 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.

You may not qualify if:

• Severe neurological or psychiatric disorder interfering with ability to give an informed consent
• No consent for registration, storage and handling of the personal data

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (30)

Hämatologische Onkologie Praxis Augsburg

Augsburg, 86150, Germany

RECRUITING

Klinikum Augsburg

Augsburg, 86156, Germany

RECRUITING

Helios Klinikum, Bad Saarow

Bad Saarow, 15526, Germany

RECRUITING

Klinikum Mittelbaden

Baden-Baden, 76532, Germany

RECRUITING

MVZ Klinikum Coburg

Coburg, 96450, Germany

RECRUITING

Donauwörth, Onko-Medeor

Donauwörth, 86609, Germany

RECRUITING

Onkologie, BAG, Dresden

Dresden, 01307, Germany

RECRUITING

Onkologie Erding

Erding, 85435, Germany

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Alb Fils Kliniken Göppingen

Göppingen, 73035, Germany

RECRUITING

Universitätsklinikum Greifswald

Greifswald, 17475, Germany

RECRUITING

Onkologische Praxis, Heidelberg

Heidelberg, 69115, Germany

WITHDRAWN

Onkologische Schwerpunktpraxis, Heilbronn

Heilbronn, 74072, Germany

WITHDRAWN

Marienhospital Bochum-Herne

Herne, 44625, Germany

RECRUITING

Universitätsklinikum Jena

Jena, 07743, Germany

RECRUITING

Klinikum Kempten-Oberallgäu gGmbH

Kempten, 87439, Germany

RECRUITING

Landshut VK&K Studien GbR

Landshut, 84036, Germany

RECRUITING

Leer, Studienzentrum Unter Ems

Leer, 26789, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Universitätsklinikum Mannheim

Mannheim, 55131, Germany

RECRUITING

Mannheim, Onkologiepraxis

Mannheim, 68161, Germany

RECRUITING

Memmingen, Onkologiepraxis

Memmingen, 87700, Germany

RECRUITING

Mühlenkreiskliniken Minden

Minden, 32429, Germany

RECRUITING

Stauferklinikum Schwäbisch Gmünd

Mutlangen, 73557, Germany

RECRUITING

Diakonie-Klinikum Stuttgart

Stuttgart, 70176, Germany

RECRUITING

Stuttgart, MVZ am RBK

Stuttgart, 70376, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

Rems-Murr-Kliniken Winnenden

Winnenden, 71334, Germany

RECRUITING

Würzburg / Kitzingen, Gemeinschaftspraxis Dr. Schlag

Würzburg, 97080, Germany

RECRUITING

Central Study Contacts

Frank Stegelmann, Dr.

CONTACT

+4973150045521; frank.stegelmann@uniklinik-ulm.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. med.

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: April 24, 2017
• Study Start: May 1, 2013
• Primary Completion (Estimated): September 1, 2045
• Study Completion (Estimated): September 1, 2045
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (30)