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

Medical University Innsbruck1 site in 1 country130 target enrollmentJanuary 22, 2020

ConditionsMyelodysplastic Syndromes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myelodysplastic Syndromes
Sponsor: Medical University Innsbruck
Enrollment: 130
Locations: 1
Primary Endpoint: Definition of correlation between molecular aberrations and the sterile inflammatory tonus
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

January 22, 2020

End Date

January 2023

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medical University Innsbruck

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Definition of correlation between molecular aberrations and the sterile inflammatory tonus

Time Frame: baseline

Definition how genetic aberrations and associated sterile inflammation impacts on health-related quality of life (HRQoL, e.g. fatigue) and functional activities in patients with MDS, MDS/MPN, or CHIP/CCUS

Time Frame: baseline

Secondary Outcomes

Definition of correlation of sterile inflammatory tonus with clinical variables (e.g. progression to secondary acute myeloid leukemia (sAML), complications (e.g. infections), and survival)(baseline)