Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03125707
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Frank Stegelmann, University of Ulm

Brief Summary:

To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 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


Condition or disease Intervention/treatment
BCR-ABL1-Negative Myeloid Neoplasms 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 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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
Study Start Date : May 2013
Estimated Primary Completion Date : January 2037
Estimated Study Completion Date : January 2038



Primary Outcome Measures :
  1. Treatment decision [ Time Frame: 20 years ]
    Treatment decision (watch and wait, standard, investigational)

  2. Response [ Time Frame: 20 years ]
    Response of treatment

  3. Overall survival [ Time Frame: 20 years ]
    Survival over the whole study duration

  4. Progression-free-survival [ Time Frame: 20 years ]
    Survival without any progression

  5. Duration of response [ Time Frame: 20 years ]
    Duration of response over the whole study duration

  6. 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. [ Time Frame: 20 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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 suspected diagnosis of one of the following BCR-ABL1-negative myeloid neoplasm:
  • Myeloproliferative neoplasm according to WHO 2008
  • Myeloid neoplasm associated with eosinophilia and abnormalities of PDGFRA, PDGFRB, or FGFR1 according to WHO 2008
  • Secondary myelofibrosis following ET or PV according to IWG-MRT 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 processing of the individual disease characteristics and course BCR-ABL1-positive chronic myeloid leukemia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125707


Contacts
Layout table for location contacts
Contact: Frank Stegelmann, Dr. +4973150045521 frank.stegelmann@uniklinik-ulm.de

Locations
Show Show 21 study locations
Sponsors and Collaborators
University of Ulm
Additional Information:

Layout table for additonal information
Responsible Party: Frank Stegelmann, Principal Investigator Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT03125707    
Other Study ID Numbers: MPN Registry - Ulm
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms