Thinking of joining a study?

Register your interest

NCT05364892 | Recruiting | ANCA-associated Vasculitis


Biocollection of Patients With ANCA Associated Vasculitis
Sponsor:

University Hospital, Brest

Brief Summary:

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.

Condition or disease

ANCA-associated Vasculitis

Intervention/treatment

Blood samples (80 mL)

Fecal samples

Urinary sample (20-40 mL)

Questionnaires

Phase

Not Applicable

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 100 participants
Masking : None (Open Label)
Primary Purpose : Diagnostic
Official Title : Biocollection of Patients With ANCA Associated Vasculitis Diagnosed Within the CERAINO Autoimmune Disease Reference Center, Part of the Global BRAISE Project (B-dependent Rare AutoImmune DiseaSES
Actual Study Start Date : October 27, 2022
Estimated Primary Completion Date : October 27, 2032
Estimated Study Completion Date : October 27, 2032
Arm Intervention/treatment

Other: ANCA-associated vasculitis - patient library

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.

Other: Blood samples (80 mL)

Other: Fecal samples

Other: Urinary sample (20-40 mL)

Other: Questionnaires

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

Biocollection of Patients With ANCA Associated Vasculitis

Location Details


Please Choose a site



Biocollection of Patients With ANCA Associated Vasculitis

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

France,

Brest University Hospital - Rheumatology Department

Brest, France, 29200

Loading...