Pruritus in systemic diseases- Cohort with Myeloproliferativeneoplasms (MPN)

Not Applicable

Recruiting

• Conditions: Pruritus in MPN; L29; D47.3; D47.4; D45; Pruritus; Essential (haemorrhagic) thrombocythaemia; Osteomyelofibrosis; Polycythaemia vera

• Registration Number: DRKS00031138
• Lead Sponsor: niklinik Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Diagnosis of a Bcr Abl negative Myeloproliferative Neoplasm according to WHO criteria
-patients with systemic pruritus (NRS = 3) or Low-itch control group NRS <3 (NRS<3 lasting for more than 6 weeks)
- Caucasian with skin type I-IV
- Written informed consent

Exclusion Criteria

- Severe neurological or psychiatric disorders, which may harm the understanding of the informed consent or a lack of linguistic understanding, reading disabilities or disabilities in sight.
- No consent for registration, storage or processing of personal data
- No consent for biomaterial donation incl. skin biopsy
- Chronic pruritus due to other diseases than MPN (e.g. medical eruption,
psychogenic pruritus)
- Pregnancy or breastfeeding
- Neurologic diseases (e.g. Multiple sclerosis, Parkinson's disease, epilepsy) or other diseases, which may affect the study examinations (e.g. HIV infection; pacemaker or implanted defibrillator)
- Skin lesions (e.g. acute injury, acid burn, cutane injuries in the biopsy region
- Tendency to abnormal scarring
- Known allergic reaction to local anesthetics, plaster or latex

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Profiling” to characterize the clinical profile of hepatic and hematological pruritus by psychophysical testing of somatosensory function. All parameters are collected in one study visit.

Secondary Outcome Measures

Name	Time	Method
Molecular Profiling” to identify pruritus-associated microbial species, gene expression patterns, structural epidermal/dermal changes and alterations in lipid composition. Clinical Profiling of patients with systemic pruritus: We aim to characterize the clinical profile of hepatic and hematological pruritus by psychophysical testing of somatosensory function and assess longitudinal changes. Based on our previous experience, we will recruit well-defined patient cohorts with myeloproliferative neoplasms (n=30; University Hospital Aachen) with pruritus (NRS = 3) as well as age-, sex- and disease-matched controls (n=30, each) with low-intensity or without pruritus (NRS < 3). (At the University Hospital Erlangen n=30 patients with hepatobiliary diseases and an additional control cohort of patients with non-MPN aquagenic pruritus will be recruited in Münster and will be analyzed for the same skin biopsy and serum parameters, allowing comparison with the above-mentioned cohorts.