Sterile Inflammation and Molecular Aberrations in MDS (InflamGen)

Medical University Innsbruck

Status: Unknown

Conditions: Myelodysplastic Syndromes

Treatments: Diagnostic Test: flow cytometry; Diagnostic Test: Clinical/demographic data; Diagnostic Test: Tumorimmunological examinations - multiplex assays/quantitative polymerase chain reaction; Diagnostic Test: Metagenomics of stool samples; Other: Elicitation of the HRQoL; Diagnostic Test: Next Generation Sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT04313231

20200129-2183

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

130 participants in 2 patient groups

MDS

Description:

* Female and male patients aged 18 years and older * MDS, MDS/MPN diagnosis based on current WHO classification. CCUS and CHIP defined by Valent (Valent, Oncotarget, 2018) and by Stauder (Stauder, Blood, 2018)

Treatment:

Diagnostic Test: Tumorimmunological examinations - multiplex assays/quantitative polymerase chain reaction

Diagnostic Test: flow cytometry

Diagnostic Test: Metagenomics of stool samples

Diagnostic Test: Next Generation Sequencing

Other: Elicitation of the HRQoL

Diagnostic Test: Clinical/demographic data

control

Description:

age-matched healthy persons

Treatment:

Diagnostic Test: Tumorimmunological examinations - multiplex assays/quantitative polymerase chain reaction

Diagnostic Test: flow cytometry

Diagnostic Test: Metagenomics of stool samples

Diagnostic Test: Next Generation Sequencing

Other: Elicitation of the HRQoL

Diagnostic Test: Clinical/demographic data