German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,172
- Locations
- 30
- Primary Endpoint
- Overall survival
Study Overview
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)
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Overall survival
Time Frame: 25 years
Survival over the whole study duration
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: 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.
Treatment decision
Time Frame: 25 years
Treatment decision (watch and wait, standard, investigational)
Response
Time Frame: 25 years
Response of treatment
Duration of response
Time Frame: 25 years
Duration of response over the whole study duration
Progression-free-survival
Time Frame: 25 years
Survival without any progression
Secondary Outcomes
No secondary outcomes reported
Investigators
Frank Stegelmann
Principal Investigator Dr. med.
University of Ulm