VasculitisBIOVASNCT05565885
Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis
An observational study of Vasculitis, run by University Hospital, Tours at 1 site in France.
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 . Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vasculitis
- What is being tested?
- Sampling
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2022to Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with vascularitis
Who may be able to join
- Age > 16 years
- Active vasculitis, new diagnosis or relapse
- IgA vasculitis
- ANCA vasculitis
- Giant cell arteritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University hospital
Tours, 37044
Alexandra Audemard Verger, 0247473715 ext. +33, alexandra.audemardverger@univ-tours.fr
Jean Michel HALIMI
About this study
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.
Read the 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.
- Conditions
- Vasculitis
- Being tested
- Sampling
- Keywords
- biomarkers, diagnosis, prognosis
- Medical subject headings
- Vasculitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingOther
4 blood sampling per patient and an additional one in case of relapse
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine/chemokine/metabolite concentrations
Analysis by méthod Luminex
Measured: Baseline
cytokine/chemokine/metabolite concentrations
Analysis by méthod Luminex
Measured: Month 1
cytokine/chemokine/metabolite concentrations
Analysis by méthod Luminex
Measured: Month 3
cytokine/chemokine/metabolite concentrations
Analysis by méthod Luminex
Measured: Month 12
cytokine/chemokine/metabolite concentrations
Analysis by méthod Luminex
Measured: date of relapse assessed up to 12 months
percentage of different non-conventional T cell populations
study by flow cytometry
Measured: Baseline
percentage of different non-conventional T cell populations
study by flow cytometry
Measured: Month 1
percentage of different non-conventional T cell populations
study by flow cytometry
Measured: Month 3
percentage of different non-conventional T cell populations
study by flow cytometry
Measured: Month 12
percentage of different non-conventional T cell populations
study by flow cytometry
Measured: date of relapse assessed up to 12 months
Secondary outcomes (20)
cytokine/chemokine/metabolite concentrations
identify a metabolomic blood profile for the prognosis of vasculitis
Measured: baseline
cytokine/chemokine/metabolite concentrations
identify a metabolomic blood profile for the prognosis of vasculitis
Measured: Month 1
cytokine/chemokine/metabolite concentrations
identify a metabolomic blood profile for the prognosis of vasculitis
Measured: Month 3
cytokine/chemokine/metabolite concentrations
identify a metabolomic blood profile for the prognosis of vasculitis
Measured: Month 12
cytokine/chemokine/metabolite concentrations
identify a metabolomic blood profile for the prognosis of vasculitis
Measured: date of relapse assessed up to 12 months
percentage of different non-conventional T cell populations
identify an immunological blood profile for the prognosis of vasculitis
Measured: baseline
percentage of different non-conventional T cell populations
identify an immunological blood profile for the prognosis of vasculitis
Measured: Month 1
percentage of different non-conventional T cell populations
identify an immunological blood profile for the prognosis of vasculitis
Measured: Month 3
percentage of different non-conventional T cell populations
identify an immunological blood profile for the prognosis of vasculitis
Measured: Month 12
percentage of different non-conventional T cell populations
identify an immunological blood profile for the prognosis of vasculitis
Measured: date of relapse assessed up to 12 months
metabolomic pathway
Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: baseline
metabolomic pathway
Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: Month 1
metabolomic pathway
Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: Month 3
metabolomic pathway
Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: Month 12
metabolomic pathway
Identify a metabolomic pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: date of relapse assessed up to 12 months
immunological pathway
Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: baseline
immunological pathway
Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: Month 1
immunological pathway
Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: Month 3
immunological pathway
Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: Month 12
immunological pathway
Identify an immunological pathway involved in the pathophysiology of vasculitis that could be a target for therapy.
Measured: date of relapse assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start22 Nov 2022
- Primary completionDec 2037 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasculitisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565885
- Sponsor's protocol ID
- DR220193-BIOVAS
- Acronym
- BIOVAS
- Status last verified
- May 2025
- First submitted
- 7 Sep 2022
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis
- ClinicalTrials.gov ID
- NCT05565885
- Acronym / sponsor ID
- BIOVAS / DR220193-BIOVAS
- Conditions
- Vasculitis
- Keywords
- biomarkers, diagnosis, prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- Dec 2037 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with vascularitis | – | Other: SamplingTwo 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with vascularitis
Key inclusion criteria (5 listed)
- Age > 16 years
- Active vasculitis, new diagnosis or relapse
- IgA vasculitis
- ANCA vasculitis
- Giant cell arteritis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling4 blood sampling per patient and an additional one in case of relapse | Other | patients with vascularitis |
Primary outcome
cytokine/chemokine/metabolite concentrations
Time frame: Baseline
Analysis by méthod Luminex
cytokine/chemokine/metabolite concentrations
Time frame: Month 1
Analysis by méthod Luminex
cytokine/chemokine/metabolite concentrations
Time frame: Month 3
Analysis by méthod Luminex
cytokine/chemokine/metabolite concentrations
Time frame: Month 12
Analysis by méthod Luminex
cytokine/chemokine/metabolite concentrations
Time frame: date of relapse assessed up to 12 months
Analysis by méthod Luminex
percentage of different non-conventional T cell populations
Time frame: Baseline
study by flow cytometry
percentage of different non-conventional T cell populations
Time frame: Month 1
study by flow cytometry
percentage of different non-conventional T cell populations
Time frame: Month 3
study by flow cytometry
percentage of different non-conventional T cell populations
Time frame: Month 12
study by flow cytometry
percentage of different non-conventional T cell populations
Time frame: date of relapse assessed up to 12 months
study by flow cytometry
20 secondary outcomes
cytokine/chemokine/metabolite concentrations
Time frame: baseline
cytokine/chemokine/metabolite concentrations
Time frame: Month 1
cytokine/chemokine/metabolite concentrations
Time frame: Month 3
cytokine/chemokine/metabolite concentrations
Time frame: Month 12
cytokine/chemokine/metabolite concentrations
Time frame: date of relapse assessed up to 12 months
percentage of different non-conventional T cell populations
Time frame: baseline
percentage of different non-conventional T cell populations
Time frame: Month 1
percentage of different non-conventional T cell populations
Time frame: Month 3
percentage of different non-conventional T cell populations
Time frame: Month 12
percentage of different non-conventional T cell populations
Time frame: date of relapse assessed up to 12 months
metabolomic pathway
Time frame: baseline
metabolomic pathway
Time frame: Month 1
metabolomic pathway
Time frame: Month 3
metabolomic pathway
Time frame: Month 12
metabolomic pathway
Time frame: date of relapse assessed up to 12 months
immunological pathway
Time frame: baseline
immunological pathway
Time frame: Month 1
immunological pathway
Time frame: Month 3
immunological pathway
Time frame: Month 12
immunological pathway
Time frame: date of relapse assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasculitis, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Audemard verger (02 47 47 37 15 ext. +33, alexandra.audemardverger@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine/chemokine/metabolite concentrations (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.