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Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05565885
Acronym
BIOVAS
Enrollment
225
Registered
2022-10-04
Start date
2022-11-22
Completion date
2037-12-31
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasculitis

Keywords

biomarkers, diagnosis, prognosis

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.

Interventions

OTHERSampling

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

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
cytokine/chemokine/metabolite concentrationsBaselineAnalysis by méthod Luminex
percentage of different non-conventional T cell populationsBaselinestudy by flow cytometry

Secondary

MeasureTime frameDescription
cytokine/chemokine/metabolite concentrationsbaselineidentify a metabolomic blood profile for the prognosis of vasculitis
percentage of different non-conventional T cell populationsbaselineidentify an immunological blood profile for the prognosis of vasculitis
metabolomic pathwaybaselineIdentify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
immunological pathwaybaselineIdentify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

Countries

France

Contacts

Primary ContactAlexandra Audemard verger
alexandra.audemardverger@univ-tours.fr02 47 47 37 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026