Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

Recruiting

• Conditions: Vasculitis

• Registration Number: NCT05565885
• Lead Sponsor: University Hospital, Tours

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-04
• Study Start: 2022-11-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-29
• Primary Completion: 2037-12
• Study Completion: 2037-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cytokine/chemokine/metabolite concentrations	date of relapse assessed up to 12 months	Analysis by méthod Luminex
percentage of different non-conventional T cell populations	date of relapse assessed up to 12 months	study by flow cytometry

Secondary Outcome Measures

Name	Time	Method
cytokine/chemokine/metabolite concentrations	date of relapse assessed up to 12 months	identify a metabolomic blood profile for the prognosis of vasculitis
percentage of different non-conventional T cell populations	date of relapse assessed up to 12 months	identify an immunological blood profile for the prognosis of vasculitis
metabolomic pathway	date of relapse assessed up to 12 months	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
immunological pathway	date of relapse assessed up to 12 months	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

Trial Locations

Locations (1)

University hospital; 🇫🇷 Tours, France