Biocollection of Patients With ANCA Associated Vasculitis

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: ANCA-associated Vasculitis

Treatments: Other: Urinary sample (20-40 mL); Other: Fecal samples; Other: Questionnaires; Other: Blood samples (80 mL)

Study type: Interventional

Funder types: Other

Identifiers

NCT05364892

29BRC20.0233

Details and patient eligibility

About

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.

Full description

Vasculitis associated with anti-neutrophil cytoplasm antibodies (ANCA) is a group of rare and severe autoimmune diseases, encompassing several entities: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (PMA), and eosinophilic granulomatosis with polyangiitis (GEPA). When untreated, these diseases are fatal in a matter of months. Currently, thanks to the use of corticosteroids and immunosuppressants, this high mortality has greatly decreased and these are now chronic diseases. On the other hand, these patients are at high risk of morbidity, linked to both relapses (occurring in at least 50% of patients) and side effects of treatments. It is therefore essential to be able to define which patients are at risk of relapse and justify long-term immunosuppressive treatment to avoid recurrence of the disease, and conversely which patients have a low risk of relapse and in whom immunosuppressive treatments can be discontinued to limit the risk of side effects. However, so far no predictor or biomarker can accurately assess this risk of relapse.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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
• Patient who has signed written informed consent

Exclusion criteria

• Minor
• Patients unable to consent.
• Patients refusing to participate in research
• Patient under legal protection (tutelage, curatorship)
• Pregnant or lactating women
• Hemoglobin (Hb) < 7g/dL

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

ANCA-associated vasculitis - patient library

Other group

Description:

It is a description of ANCA-associated vasculitis patients cohort. All the patients are included in one arm. They will undergo various type of samples.

Treatment:

Other: Questionnaires

Other: Blood samples (80 mL)

Other: Fecal samples

Other: Urinary sample (20-40 mL)