Ireland
--:--IST
Starting soon Observational

Biomarkers in Systemic Histiocytosis

NCT07157683 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-10-01
Last updated
2025-09-05

Condition(s) studied

Systemic Histiocytosis (Disorder)

Investigational drug(s) / intervention(s)

Biospecimen collection

Biospecimen collection: If a blood sample is drawn as part of standard care, up to six additional EDTA tubes (42 mL max) will be collected for research. In addition, the following optional samples may be collected, depending on investigator assessment and/or patient preference: * Saliva sample (if no blood draw is performed) * Urine sample * Stool sample"

Study summary

Systemic histiocytoses in adults (Langerhans cell histiocytosis, Erdheim-Chester disease, and Rosai-Dorfman disease) are rare inflammatory disorders in which recent discoveries have identified a clonal origin, with activating mutations in the MAP kinase pathway, enabling access to targeted therapies. However, the mechanism by which these mutations induce an inflammatory profile in tissue histiocytes remains largely unknown.

Despite these advances, there is a clear need to refine diagnostic and prognostic classification, to identify the biological mechanisms involved in the onset and progression of these diseases, to develop new targeted strategies, and to establish minimally invasive monitoring methods (liquid biopsies).

This project aims to make a decisive contribution toward these goals.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Patient followed for systemic histiocytosis in Internal Medicine Department 2 at Pitié-Salpêtrière Hospital * Non-opposition to participation in the study Exclusion Criteria: * Pregnant or breastfeeding women * Patients without French social security or covered by State Medical Aid (AME) * Patients deprived of liberty by judicial or administrative decision, or under legal protection

Primary outcome measure(s)

  • Identification of new biomarkers involved in histiocytosis — 10 years
    Plasma concentrations of several cytokines and chemokines involved in inflammation and fibrosis will be assessed using ELISA and Luminex assays (CSF, EGF, GM-CSF, FGF-basic, IFN-α, MCP-1, HGF, IFN-γ, MIG, VEGF, IL-1β, MIP-1α, IL-1RA, MIP-1β, IL-2, RANTES, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p40/p70), IL-13, IL-15, IL-17, TNF-α, and Eotaxin),

Trial sites (1)

FacilityCityRegionStatus
Internal Medicine Department 2 at Pitié-Salpêtrière Hospital Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07157683 on ClinicalTrials.gov ↗ ← All trials in France