Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

Vasculitis Clinical Trial

— BIOVAS  

Official title:

Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565885
• Other study ID #: DR220193-BIOVAS
• Status: Recruiting
• Start date: November 22, 2022
• Est. completion date: December 2037

Study information

• Verified date: February 2024
• Source: University Hospital, Tours
• Contact: Alexandra Audemard verger
• Phone: 02 47 47 37 15
• Email: alexandra.audemardverger[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 2037
• Est. primary completion date: December 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vasculitis

Intervention

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

Locations

Country	Name	City	State
France	University hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokine/chemokine/metabolite concentrations	Analysis by méthod Luminex	Baseline
Primary	cytokine/chemokine/metabolite concentrations	Analysis by méthod Luminex	Month 1
Primary	cytokine/chemokine/metabolite concentrations	Analysis by méthod Luminex	Month 3
Primary	cytokine/chemokine/metabolite concentrations	Analysis by méthod Luminex	Month 12
Primary	cytokine/chemokine/metabolite concentrations	Analysis by méthod Luminex	date of relapse assessed up to 12 months
Primary	percentage of different non-conventional T cell populations	study by flow cytometry	Baseline
Primary	percentage of different non-conventional T cell populations	study by flow cytometry	Month 1
Primary	percentage of different non-conventional T cell populations	study by flow cytometry	Month 3
Primary	percentage of different non-conventional T cell populations	study by flow cytometry	Month 12
Primary	percentage of different non-conventional T cell populations	study by flow cytometry	date of relapse assessed up to 12 months
Secondary	cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	baseline
Secondary	cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	Month 1
Secondary	cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	Month 3
Secondary	cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	Month 12
Secondary	cytokine/chemokine/metabolite concentrations	identify a metabolomic blood profile for the prognosis of vasculitis	date of relapse assessed up to 12 months
Secondary	percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	baseline
Secondary	percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	Month 1
Secondary	percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	Month 3
Secondary	percentage of different non-conventional T cell populations	identify an immunological blood profile for the prognosis of vasculitis	Month 12
Secondary	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
Secondary	metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	baseline
Secondary	metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 1
Secondary	metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 3
Secondary	metabolomic pathway	Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 12
Secondary	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
Secondary	immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	baseline
Secondary	immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 1
Secondary	immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 3
Secondary	immunological pathway	Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.	Month 12
Secondary	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