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NCT Number: NCT05565885

Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

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.

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Key information

Conditions

Vasculitis Cardiovascular Diseases Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital

Tours, 37044, France

Location status: Recruiting

Location contact

Alexandra Audemard Verger

CONTACT

[email protected]

0247473715 ext. +33

François MAILLOT

SUB_INVESTIGATOR

Isabelle GRIFFOUL

SUB_INVESTIGATOR

Jean Michel HALIMI

SUB_INVESTIGATOR

Laurent MACHET

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sampling

Other

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

Primary outcomes

  1. cytokine/chemokine/metabolite concentrations

    Time frame: Baseline

    Analysis by méthod Luminex

  2. cytokine/chemokine/metabolite concentrations

    Time frame: Month 1

    Analysis by méthod Luminex

  3. cytokine/chemokine/metabolite concentrations

    Time frame: Month 3

    Analysis by méthod Luminex

  4. cytokine/chemokine/metabolite concentrations

    Time frame: Month 12

    Analysis by méthod Luminex

  5. cytokine/chemokine/metabolite concentrations

    Time frame: date of relapse assessed up to 12 months

    Analysis by méthod Luminex

  6. percentage of different non-conventional T cell populations

    Time frame: Baseline

    study by flow cytometry

  7. percentage of different non-conventional T cell populations

    Time frame: Month 1

    study by flow cytometry

  8. percentage of different non-conventional T cell populations

    Time frame: Month 3

    study by flow cytometry

  9. percentage of different non-conventional T cell populations

    Time frame: Month 12

    study by flow cytometry

  10. percentage of different non-conventional T cell populations

    Time frame: date of relapse assessed up to 12 months

    study by flow cytometry

Secondary outcomes

  1. cytokine/chemokine/metabolite concentrations

    Time frame: baseline

    identify a metabolomic blood profile for the prognosis of vasculitis

  2. cytokine/chemokine/metabolite concentrations

    Time frame: Month 1

    identify a metabolomic blood profile for the prognosis of vasculitis

  3. cytokine/chemokine/metabolite concentrations

    Time frame: Month 3

    identify a metabolomic blood profile for the prognosis of vasculitis

  4. cytokine/chemokine/metabolite concentrations

    Time frame: Month 12

    identify a metabolomic blood profile for the prognosis of vasculitis

  5. cytokine/chemokine/metabolite concentrations

    Time frame: date of relapse assessed up to 12 months

    identify a metabolomic blood profile for the prognosis of vasculitis

  6. percentage of different non-conventional T cell populations

    Time frame: baseline

    identify an immunological blood profile for the prognosis of vasculitis

  7. percentage of different non-conventional T cell populations

    Time frame: Month 1

    identify an immunological blood profile for the prognosis of vasculitis

  8. percentage of different non-conventional T cell populations

    Time frame: Month 3

    identify an immunological blood profile for the prognosis of vasculitis

  9. percentage of different non-conventional T cell populations

    Time frame: Month 12

    identify an immunological blood profile for the prognosis of vasculitis

  10. percentage of different non-conventional T cell populations

    Time frame: date of relapse assessed up to 12 months

    identify an immunological blood profile for the prognosis of vasculitis

  11. metabolomic pathway

    Time frame: baseline

    Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

  12. metabolomic pathway

    Time frame: Month 1

    Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

  13. metabolomic pathway

    Time frame: Month 3

    Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

  14. metabolomic pathway

    Time frame: Month 12

    Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

  15. metabolomic pathway

    Time frame: 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.

  16. immunological pathway

    Time frame: baseline

    Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

  17. immunological pathway

    Time frame: Month 1

    Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

  18. immunological pathway

    Time frame: Month 3

    Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

  19. immunological pathway

    Time frame: Month 12

    Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.

  20. immunological pathway

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Audemard verger

CONTACT

[email protected]

02 47 47 37 15 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: BIOVAS

Important dates

Study start
2022
Primary completion
2037
Study completion
2037
First posted
Oct 4, 2022
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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