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

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

Study Overview

• Status: Recruiting
• Conditions: BCR-ABL1-Negative Myeloid Neoplasms
• Intervention / Treatment: Other: Registry study

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

• Study Type: Observational
• Enrollment (Anticipated): 2172

Contacts and Locations

• Study Contact: Name: Frank Stegelmann, Dr.; Phone Number: +4973150045521; Email: frank.stegelmann@uniklinik-ulm.de

Study Locations

• Germany
  • Augsburg, Germany, 86150
    • Recruiting
    • Hämatologische Onkologie Praxis Augsburg
    • Contact: Markus Bangerter, MD; Phone Number: +498213446520; Email: markus.bangerter@hop-augsburg.de
  • Augsburg, Germany, 86156
    • Recruiting
    • Klinikum Augsburg
    • Contact: Klaus Hirschbühl, MD; Phone Number: +498214003715; Email: klaus.hirschbuehl@klinikum-augsburg.de
  • Bad Saarow, Germany, 15526
    • Recruiting
    • Helios Klinikum, Bad Saarow
    • Contact: Daniel Schöndube, MD; Phone Number: +493363173728; Email: daniel.schoendube@helios-kliniken.de
  • Baden-Baden, Germany, 76532
    • Recruiting
    • Klinikum Mittelbaden
    • Contact: Jutta Hagemeyer, MD; Phone Number: +497221/91-4126; Email: j.hagemeyer@klinikum-mittelbaden.de
  • Coburg, Germany, 96450
    • Recruiting
    • MVZ Klinikum Coburg
    • Contact: Christof Lamberti, MD; Phone Number: +49956122-34607; Email: christof.lamberti@klinikum-coburg.de
  • Donauwörth, Germany, 86609
    • Recruiting
    • Donauwörth, Onko-Medeor
    • Contact: Dirk Hempel, MD; Phone Number: +49906299939-0; Email: donauwoerth@onko-medeor.de
  • Dresden, Germany, 01307
    • Recruiting
    • Onkologie, BAG, Dresden
    • Contact: Thomas Illmer, MD; Phone Number: +493514400022; Email: illmer@onkologie-dresden.de
  • Erding, Germany, 85435
    • Recruiting
    • Onkologie Erding
    • Contact: Stefanie Jilg, MD; Phone Number: +49 8122 959139; Email: stefanie.jilg@onkologie-erding.de
  • Freiburg, Germany, 79106
    • Recruiting
    • Universitatsklinikum Freiburg
    • Contact: Cornelius Waller, MD; Phone Number: +497612700; Email: cornelius.waller@uniklinik-freiburg.de
  • Greifswald, Germany, 17475
    • Recruiting
    • Universitätsklinikum Greifswald
    • Contact: Florian Heidel, MD; Phone Number: +493834 - 86 22006; Email: florian.heidel@med.uni-greifswald.de
  • Göppingen, Germany, 73035
    • Recruiting
    • Alb Fils Kliniken Göppingen
    • Contact: Martin Bommer, MD; Phone Number: +497161642962; Email: martin.bommer@af-k.de
  • Heidelberg, Germany, 69115
    • Withdrawn
    • Onkologische Praxis, Heidelberg
  • Heilbronn, Germany, 74072
    • Withdrawn
    • Onkologische Schwerpunktpraxis, Heilbronn
  • Herne, Germany, 44625
    • Recruiting
    • Marienhospital Bochum-Herne
    • Contact: Dirk Strumberg, MD; Phone Number: +4923234991575; Email: onkologie@marienhospital-herne.de
  • Jena, Germany, 07743
    • Recruiting
    • Universitätsklinikum Jena
    • Contact: Andreas Hochhaus, MD; Phone Number: 9324216 03641; Email: andreas.hochhaus@med.uni-jena.de
  • Kempten, Germany, 87439
    • Recruiting
    • Klinikum Kempten-Oberallgäu gGmbH
    • Contact: Christian Langer, MD; Phone Number: 2245 +49831530; Email: christian.langer@klinikum-kempten.de
  • Landshut, Germany, 84036
    • Recruiting
    • Landshut VK&K Studien GbR
    • Contact: Ana Hoffmann, MD; Phone Number: 429 087197403; Email: ana.hoffmann@vehling-kaiser.de
  • Leer, Germany, 26789
    • Active, not recruiting
    • Leer, Studienzentrum Unter Ems
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitatsklinikum Leipzig
    • Contact: Madlen Jentzsch, MD; Phone Number: +493419713061; Email: madlen.jentzsch@medizin.uni-leipzig.de
  • Magdeburg, Germany, 39120
    • Recruiting
    • Universitätsklinikum Magdeburg
    • Contact: Denise Wolleschak, MD; Phone Number: +4916713134; Email: denise.wolleschak@med.ovgu.de
  • Mannheim, Germany, 55131
    • Recruiting
    • Universitätsklinikum Mannheim
    • Contact: Andreas Reiter, MD; Phone Number: +496213830; Email: andreas.reiter@umm.de
  • Mannheim, Germany, 68161
    • Recruiting
    • Mannheim, Onkologiepraxis
    • Contact: Manfred Hensler, MD; Phone Number: +49621-22430; Email: info@mannheimer-onkologie-praxis.de
  • Memmingen, Germany, 87700
    • Recruiting
    • Memmingen, Onkologiepraxis
    • Contact: Juergen Jaeckle, MD; Phone Number: +498331 75049-00; Email: jaeckle@onkologie-mm.de
  • Minden, Germany, 32429
    • Recruiting
    • Mühlenkreiskliniken Minden
    • Contact: Martin Griesshammer, MD; Phone Number: +495717901184; Email: martin.griesshammer@muehlenkreiskliniken.de
  • Mutlangen, Germany, 73557
    • Recruiting
    • Stauferklinikum Schwäbisch Gmünd
    • Contact: Holger Hebart, MD; Phone Number: +4971717011397; Email: holger.hebart@kliniken-ostalb.de
  • Stuttgart, Germany, 70176
    • Recruiting
    • Diakonie-Klinikum Stuttgart
    • Contact: Jochen Greiner, MD; Phone Number: +497119913517; Email: greiner@diak-stuttgart.de
  • Stuttgart, Germany, 70376
    • Recruiting
    • Stuttgart, MVZ am RBK
    • Contact: Ulrike Schwinger, MD; Phone Number: 0711-8101-5983; Email: ulrike.schwinger@rbk-mvz.de
  • Ulm, Germany, 89081
    • Recruiting
    • Universitatsklinikum Ulm
    • Contact: Frank Stegelmann, MD; Phone Number: 45928 +49731500; Email: frank.stegelmann@uniklinik-ulm.de
  • Winnenden, Germany, 71334
    • Recruiting
    • Rems-Murr-Kliniken Winnenden
    • Contact: Julia Glueck-Wolf; Phone Number: +49719559136031; Email: julia.glueck-wolf@rems-murr-kliniken.de
  • Würzburg, Germany, 97080
    • Recruiting
    • Würzburg / Kitzingen, Gemeinschaftspraxis Dr. Schlag
    • Contact: Bjoern Schoettker, MD; Phone Number: +49931322670; Email: b.schoettker@onkopraxis-wuerzburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Ulm

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): September 1, 2045
• Study Completion (Anticipated): September 1, 2045

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MPN Registry - Ulm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No