Recruiting
NCT Number: NCT03125707
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Hämatologische Onkologie Praxis Augsburg, Augsburg, Germany
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About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Treatment decision
Time frame: 25 years
Treatment decision (watch and wait, standard, investigational)
-
Response
Time frame: 25 years
Response of treatment
-
Overall survival
Time frame: 25 years
Survival over the whole study duration
-
Progression-free-survival
Time frame: 25 years
Survival without any progression
-
Duration of response
Time frame: 25 years
Duration of response 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Ulm
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2045
- Study completion
- 2045
- First posted
- Apr 24, 2017
- Registry last updated
- May 19, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.