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Recruiting NCT05565885

Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

— Observational Vasculitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sampling.
Who it may be relevant to
Registry conditions: Vasculitis. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Specimen will be collected at diagnosis, month 1, month 3, and month12 and at the time of a possible relapse. 14 ml of additional blood during a blood puncture made for routine care will be collected at each visit as well as clinical data.

Interventions

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

Primary outcome measures

  • cytokine/chemokine/metabolite concentrations [Time frame: Baseline]
  • cytokine/chemokine/metabolite concentrations [Time frame: Month 1]
  • cytokine/chemokine/metabolite concentrations [Time frame: Month 3]
  • cytokine/chemokine/metabolite concentrations [Time frame: Month 12]
  • cytokine/chemokine/metabolite concentrations [Time frame: date of relapse assessed up to 12 months]
  • percentage of different non-conventional T cell populations [Time frame: Baseline]
  • percentage of different non-conventional T cell populations [Time frame: Month 1]
  • percentage of different non-conventional T cell populations [Time frame: Month 3]
  • percentage of different non-conventional T cell populations [Time frame: Month 12]
  • percentage of different non-conventional T cell populations [Time frame: date of relapse assessed up to 12 months]
Secondary outcome measures (12)
  • cytokine/chemokine/metabolite concentrations [Time frame: baseline]
  • cytokine/chemokine/metabolite concentrations [Time frame: Month 1]
  • cytokine/chemokine/metabolite concentrations [Time frame: Month 3]
  • cytokine/chemokine/metabolite concentrations [Time frame: Month 12]
  • cytokine/chemokine/metabolite concentrations [Time frame: date of relapse assessed up to 12 months]
  • percentage of different non-conventional T cell populations [Time frame: baseline]
  • percentage of different non-conventional T cell populations [Time frame: Month 1]
  • percentage of different non-conventional T cell populations [Time frame: Month 3]
  • percentage of different non-conventional T cell populations [Time frame: Month 12]
  • percentage of different non-conventional T cell populations [Time frame: date of relapse assessed up to 12 months]
  • metabolomic pathway [Time frame: baseline]
  • metabolomic pathway [Time frame: Month 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • University hospital — Tours

Identifiers

NCT: NCT05565885 · DR220193-BIOVAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗