Sterile Inflammation and Molecular Aberrations in MDS

Sterile Inflammation and Molecular Aberrations in Myelodysplastic Syndrome: Determinants of Quality of Life and Vulnerability

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 gaining a better understanding of the causal correlation between genetics, sterile inflammatory processes and QoL (e.g. fatigue) in MDS, this study is supposed to identify potential novel biomarkers and, ultimately, therapeutic targets.

Inclusion Criteria:

• 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 Criteria:

• 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