Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

NCT ID: NCT05565885

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-22

Study Completion Date

2037-12-31

Brief Summary

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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

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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.

Conditions

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Vasculitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Sampling

Intervention Type OTHER

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

Interventions

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Sampling

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University hospital

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alexandra Audemard verger

Role: CONTACT

02 47 47 37 15 ext. +33

Facility Contacts

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Alexandra Audemard Verger

Role: primary

0247473715 ext. +33

Other Identifiers

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DR220193-BIOVAS

Identifier Type: -

Identifier Source: org_study_id

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