NCT05565885

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
141mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Nov 2022Dec 2037

First Submitted

Initial submission to the registry

September 7, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 22, 2022

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2037

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

15 years

First QC Date

September 7, 2022

Last Update Submit

May 22, 2025

Conditions

Vasculitis

Keywords

biomarkersdiagnosisprognosis

Outcome Measures

Primary Outcomes (10)

  • cytokine/chemokine/metabolite concentrations

    Analysis by méthod Luminex

    Baseline

  • cytokine/chemokine/metabolite concentrations

    Analysis by méthod Luminex

    Month 1

  • cytokine/chemokine/metabolite concentrations

    Analysis by méthod Luminex

    Month 3

  • cytokine/chemokine/metabolite concentrations

    Analysis by méthod Luminex

    Month 12

  • cytokine/chemokine/metabolite concentrations

    Analysis by méthod Luminex

    date of relapse assessed up to 12 months

  • percentage of different non-conventional T cell populations

    study by flow cytometry

    Baseline

  • percentage of different non-conventional T cell populations

    study by flow cytometry

    Month 1

  • percentage of different non-conventional T cell populations

    study by flow cytometry

    Month 3

  • percentage of different non-conventional T cell populations

    study by flow cytometry

    Month 12

  • percentage of different non-conventional T cell populations

    study by flow cytometry

    date of relapse assessed up to 12 months

Secondary Outcomes (20)

  • cytokine/chemokine/metabolite concentrations

    baseline

  • cytokine/chemokine/metabolite concentrations

    Month 1

  • cytokine/chemokine/metabolite concentrations

    Month 3

  • cytokine/chemokine/metabolite concentrations

    Month 12

  • cytokine/chemokine/metabolite concentrations

    date of relapse assessed up to 12 months

  • +15 more secondary outcomes

Study Arms (1)

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

Other: Sampling

Interventions

SamplingOTHER

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

patients with vascularitis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with vascularitis

You may qualify if:

  • Age \> 16 years
  • Active vasculitis, new diagnosis or relapse
  • IgA vasculitis
  • ANCA vasculitis
  • Giant cell arteritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Tours, 37044, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sampling at diagnosis, at M1, M3, M12 and at the time of a possible relapse: 14 ml of additional blood during a blood puncture for routine care will be collected at each visit together with clinical data.

MeSH Terms

Conditions

VasculitisDisease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandra Audemard verger

CONTACT

02 47 47 37 15alexandra.audemardverger@univ-tours.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

October 4, 2022

Study Start

November 22, 2022

Primary Completion (Estimated)

December 1, 2037

Study Completion (Estimated)

December 1, 2037

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations

FR(1)