Biocollection of Patients With ANCA Associated Vasculitis

NCT ID: NCT05364892

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-27
• Study Completion Date: 2032-10-27

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.

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.

Conditions

ANCA-associated Vasculitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Blood samples (80 mL)

Intervention Type: OTHER

Blood samples (80 mL) at inclusion, once a year for 5 years, and if relapse or change of treatment

Fecal samples

Intervention Type: OTHER

Fecal samples at inclusion

Urinary sample (20-40 mL)

Intervention Type: OTHER

Urinary samples at inclusion, once a year for 5 years, and if relapse or change of treatment

Questionnaires

Intervention Type: OTHER

Questionnaires at inclusion, once a year for 5 years, and if relapse or change of treatment

Interventions

Blood samples (80 mL)

Blood samples (80 mL) at inclusion, once a year for 5 years, and if relapse or change of treatment

Intervention Type: OTHER

Fecal samples

Fecal samples at inclusion

Intervention Type: OTHER

Urinary sample (20-40 mL)

Urinary samples at inclusion, once a year for 5 years, and if relapse or change of treatment

Intervention Type: OTHER

Questionnaires

Questionnaires at inclusion, once a year for 5 years, and if relapse or change of treatment

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU de Brest - Service de rhumatologie

Brest, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Divi CORNEC

Role: CONTACT

divi.cornec@chu-brest.fr

(0)2 98 34 72 64 ext. +33

Facility Contacts

Divi CORNEC

Role: primary

divi.cornec@chu-brest.fr

02 98 34 72 64

Other Identifiers

29BRC20.0233

Identifier Type: -

Identifier Source: org_study_id