M34.0
Conditions
Interventions
Group 1: Systemic Sclerosis (Scleroderma)
Patients with a confirmed diagnosis of systemic sclerosis.
blood Assessments are performed before extracorporeal photopheresis (ECP), immediately after ECP,
Sponsors
Universitätsklinikum Augsburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis: systemic sclerosis (scleroderma); healthy controls without family history of autoimmune or malignant disease, without evidence of immune activation or current/previous cancer therapy; graft-versus-host disease (GvHD) or other immunological diseases such as acute Sézary syndrome and T-cell lymphoma, psoriasis, and pemphigus Planned treatment with extracorporeal photopheresis (ECP) Written informed consent to participate Age over 18 years Ability to read and understand the German language is required
Exclusion criteria
Exclusion criteria: Lack of informed consent Smoking or alcohol abuse Active infection or other contraindications to blood sampling Cardiovascular or thrombotic diseases, including myocardial infarction, stroke, venous thrombosis, or peripheral arterial disease within the last 12 months; chronic heart failure NYHA class III–IV BMI > 30 kg/m² (obesity) Diabetes mellitus: known type 1 or type 2 diabetes or HbA1c > 6.5% Pregnancy or breastfeeding Continuous anticoagulant therapy (e.g., phenprocoumon/Marcumar, direct oral anticoagulants, heparin) Platelet disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the amount of ng/mL circulating cell-free DNA in patients before and after extracorporeal photopheresis | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the state (oxidized, methylated). | — |
Countries
Germany
Contacts
Public ContactVerena Raker
Universitätsklinikum Augsburg
Outcome results
None listed