Clinical trial NCT05565885: Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis
Official title: Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vasculitis
Keywords: biomarkers
diagnosis
prognosis
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 225
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with vascularitis

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.

Eligibility criteria: 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

Primary outcomes:
measure: cytokine/chemokine/metabolite concentrations
timeFrame: Baseline
measure: cytokine/chemokine/metabolite concentrations
timeFrame: Month 1
measure: cytokine/chemokine/metabolite concentrations
timeFrame: Month 3
measure: cytokine/chemokine/metabolite concentrations
timeFrame: Month 12
measure: cytokine/chemokine/metabolite concentrations
timeFrame: date of relapse assessed up to 12 months
measure: percentage of different non-conventional T cell populations
timeFrame: Baseline
measure: percentage of different non-conventional T cell populations
timeFrame: Month 1
measure: percentage of different non-conventional T cell populations
timeFrame: Month 3
measure: percentage of different non-conventional T cell populations
timeFrame: Month 12
measure: percentage of different non-conventional T cell populations
timeFrame: date of relapse assessed up to 12 months
Secondary outcomes:
measure: cytokine/chemokine/metabolite concentrations
timeFrame: baseline
measure: cytokine/chemokine/metabolite concentrations
timeFrame: Month 1
measure: cytokine/chemokine/metabolite concentrations
timeFrame: Month 3
measure: cytokine/chemokine/metabolite concentrations
timeFrame: Month 12
measure: cytokine/chemokine/metabolite concentrations
timeFrame: date of relapse assessed up to 12 months
measure: percentage of different non-conventional T cell populations
timeFrame: baseline
measure: percentage of different non-conventional T cell populations
timeFrame: Month 1
measure: percentage of different non-conventional T cell populations
timeFrame: Month 3
measure: percentage of different non-conventional T cell populations
timeFrame: Month 12
measure: percentage of different non-conventional T cell populations
timeFrame: date of relapse assessed up to 12 months
measure: metabolomic pathway
timeFrame: baseline
measure: metabolomic pathway
timeFrame: Month 1
measure: metabolomic pathway
timeFrame: Month 3
measure: metabolomic pathway
timeFrame: Month 12
measure: metabolomic pathway
timeFrame: date of relapse assessed up to 12 months
measure: immunological pathway
timeFrame: baseline
measure: immunological pathway
timeFrame: Month 1
measure: immunological pathway
timeFrame: Month 3
measure: immunological pathway
timeFrame: Month 12
measure: immunological pathway
timeFrame: date of relapse assessed up to 12 months
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital
Study officials:
References: