Biocollection of Patients With ANCA Associated Vasculitis
ConditionANCA-associated Vasculitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity Hospital, Brest
About this trial
As rare disease, vasculitis affects a small number of patients, the cohorts available in the literature are few and the pathophysiological mechanisms remain to be elucidated. The collection of standardized data within a patientheque as part of a multi-year follow-up will facilitate the study of the characteristics of these diseases. This may, in particular, address the main objective of identifying predictors of relapse, as well as secondary objectives for predictive factors of mortality, infectious, cardiovascular or neoplastic complications that affect the prognosis of vasculitis in order to establish a more appropriate management of the patients concerned.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Major patients with no upper age limit.
Patients assessed as part of the reference centre for rare autoimmune diseases at the CHRU in Brest.
Patients for whom a diagnosis of ANCA-associated vasculitis is made by the physician in charge of the patient, according to the definitions of the Chapel-Hill Consensus Conference.
Patient affiliated with Social Security
Disqualifiers
Minor
Patients unable to consent.
Patients refusing to participate in research
Patient under legal protection (tutelage, curatorship)
Trial design
Design model
Single group
Treatments tested in this trial
Blood samples (80 mL)
Other interventionBlood samples (80 mL) at inclusion, once a year for 5 years, and if relapse or change of treatment
Fecal samples
Other interventionFecal samples at inclusion
Urinary sample (20-40 mL)
Other interventionUrinary samples at inclusion, once a year for 5 years, and if relapse or change of treatment
Questionnaires
Other interventionQuestionnaires at inclusion, once a year for 5 years, and if relapse or change of treatment
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ANCA-associated vasculitis - patient libraryOther 4 interventions
Trial outcomes
Primary outcomes
1
Relapse-free survival of the disease
Relapse-free survival of the disease
Time frame
Five years after diagnosisSecondary outcomes
1
death
death
Time frame
Five years after diagnosis2
Age
Age
Time frame
Five years after diagnosis3
Sex
Sex
Time frame
Five years after diagnosis4
Physician assessment of disease activity
Disease activity will be assessed on a scale from 0 to 100, considering the pain and the impact on daily life. A higher score means a worse outcome.
Time frame
Five years after diagnosisSponsors and contacts
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Source ClinicalTrials.gov