Identifying biomarkers in systemic sclerosis and inflammatory myopathies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify diagnostic and prognostic biomarkers in patients with systemic sclerosis and inflammatory myopathies through a cohort approach. Participants will be classified into four populations based on their clinical and biological characteristics, and will undergo multiple sampling points over a five-year follow-up period. The study will utilize multi-omics analyses, including single-cell RNA sequencing, proteomics, and genomics, to characterize blood and tissue samples. The goal is to discover molecular signatures that correlate with disease characteristics and progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Control population without inflammatory myopathy (population 1), suspected myopathy for whom a blood test and muscle biopsy are required to confirm the diagnosis
* Confirmed inflammatory myopathy (population 2)
* Control population without systemic sclerosis (population 3), with primary Raynaud's phenomenon
* Early diffuse systemic cutaneous scleroderma (population 4)
* Male or female (age ≥ 18, no upper age limit)

Exclusion Criteria:

Populations 1 \& 2

* Contraindication to muscle biopsy
* Diagnosed for another neuromuscular disease
* Taking an immunosuppressant / immunomodulator treatment within 3 months before inclusion
* Unbalanced cardiovascular pathology

Population 3 \& 4

* Contraindication to skin biopsy
* Capillaroscopic and / or immunological anomaly suggesting scleroderma
* Suspicion of scleroderma but diagnosed for another connectivitis
* Immunosuppressive treatment (corticosteroids\> 15 mg, methotrexate, mycophenolate mofetil) introduced for more than 1 month
* Active or recent cancer \<3 years (apart from non-melanoma skin cancer).

For all

\- Pregnancy or breast feeding

Where it's running

• University Hospital of Hautepierre
  Strasbourg, Bas-Rhin, France Recruiting

Study contacts

• Study coordinator: Alain MEYER, MD
• Email: alain.meyer1@chru-strasbourg.fr
• Phone: + 33 3 88 12 79 55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.