Status:
UNKNOWN
Sterile Inflammation and Molecular Aberrations in MDS
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
University Hospital, Bonn
Universitätsklinikum Leipzig
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is the description of the possible association between genetic mutation/aberration profiles, inflammatory tonus and clinical phenotype based on PROMs and HRQoL. Apart from ...
Eligibility Criteria
Inclusion
- Female and male patients \> 18 years
- MDS, MDS/MPN diagnosis based on current WHO classification. CCUS and CHIP defined by Valent (Valent, Oncotarget, 2018) and by Stauder (Stauder, Blood, 2018)
- Signed and dated declaration of consent by the patient according to ICH-GCP Guidelines
Exclusion
- Any other illness, whether physical or mental, or any laboratory abnormalities which prevent a declaration of consent by the patient
- Patients with an acute and/or uncontrolled infection, including patients that are afebrile under treatment with antibiotic/antifungal/antiviral prophylactic medication
- Any pre-existing autoimmune disease requiring a systemic immunosuppression
- Steroid therapy (\>10mg Prednison/day or equivalent), regardless of its necessity up to 4 weeks before inclusion in the study
- Anamnestic and/or current therapy with hypomethylating agents (HMA) or immunomodulatory imide drugs (IMiDs)
- Status post allogenic stem cell transplantation
- Previous or ongoing chemotherapy
- Pregnancy or breastfeeding period
Key Trial Info
Start Date :
January 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04313231
Start Date
January 22 2020
End Date
January 1 2023
Last Update
April 7 2022
Active Locations (1)
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1
Medical University of Innsbruck
Innsbruck, Tyrol, Austria, 6020