Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis (BIOVAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Vasculitis
• Intervention / Treatment: Other: Sampling

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 Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

• Study Contact: Name: Alexandra Audemard verger; Phone Number: +33 02 47 47 37 15; Email: alexandra.audemardverger@univ-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Recruiting
    • University Hospital
    • Contact: Alexandra Audemard Verger; Phone Number: +33 0247473715; Email: alexandra.audemardverger@univ-tours.fr
    • Sub-Investigator: Jean Michel HALIMI
    • Sub-Investigator: Laurent MACHET
    • Sub-Investigator: Isabelle GRIFFOUL
    • Sub-Investigator: François MAILLOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with vascularitis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with vascularitis; Two additional 7ml EDTA tubes of blood are taken from the same blood puncture as during routine follow-up at several points in the follow-up	Other: Sampling; 4 blood sampling per patient and an additional one in case of relapse

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	baseline
cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	Month 1
cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	Month 3
cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	Month 12
cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	date of relapse assessed up to 12 months
percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	baseline
percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	Month 1
percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	Month 3
percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	Month 12
percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	date of relapse assessed up to 12 months
metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	baseline
metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 1
metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 3
metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 12
metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	date of relapse assessed up to 12 months
immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	baseline
immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 1
immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 3
immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 12
immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	date of relapse assessed up to 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2037

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: biomarkers; prognosis; diagnosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Vasculitis
• Other Study ID Numbers: DR220193-BIOVAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No