Ireland
--:--IST
Recruiting Observational

Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

NCT05565885 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2022-11-22
Last updated
2025-05-29

Condition(s) studied

Vasculitis

Investigational drug(s) / intervention(s)

Sampling

Sampling: 4 blood sampling per patient and an additional one in case of relapse

Study summary

To date, there are no reliable diagnostic blood markers of adult vasculitis. To date, the diagnosis of vasculitis is based on invasive procedure, biopsy of affected tissues potentially at risk of complication . In addition, there are no reliable biomarkers to predict the evolution of vasculitis (relapse, refractory form ...) necessary for the management of patients (type of treatment, duration ..)

Prospective study, monocentric (CHU de Tours), non-interventional, aimed at finding diagnostic and prognostic biomarkers (both metabolomic and immunologic) in adult vasculitis patients.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \> 16 years * Active vasculitis, new diagnosis or relapse * IgA vasculitis * ANCA vasculitis * Giant cell arteritis Exclusion Criteria: * Person who has objected to the processing of data * Pregnant woman * Patient positive for HIV, HBV, HCV * Treatment in the previous month with corticosteroids, immunosuppressive drugs or biotherapy. * Patient unable to understand the information leaflet * Adult under guardianship or curatorship

Primary outcome measure(s)

  • cytokine/chemokine/metabolite concentrations — Baseline
    Analysis by méthod Luminex
  • cytokine/chemokine/metabolite concentrations — Month 1
    Analysis by méthod Luminex
  • cytokine/chemokine/metabolite concentrations — Month 3
    Analysis by méthod Luminex
  • cytokine/chemokine/metabolite concentrations — Month 12
    Analysis by méthod Luminex
  • cytokine/chemokine/metabolite concentrations — date of relapse assessed up to 12 months
    Analysis by méthod Luminex
  • percentage of different non-conventional T cell populations — Baseline
    study by flow cytometry
  • percentage of different non-conventional T cell populations — Month 1
    study by flow cytometry
  • percentage of different non-conventional T cell populations — Month 3
    study by flow cytometry
  • percentage of different non-conventional T cell populations — Month 12
    study by flow cytometry
  • percentage of different non-conventional T cell populations — date of relapse assessed up to 12 months
    study by flow cytometry

Trial sites (1)

FacilityCityRegionStatus
University hospital Tours France Recruiting
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 NCT05565885 on ClinicalTrials.gov ↗ ← All trials in France