Biocollection of Patients With ANCA Associated Vasculitis

NCT05364892 | Recruiting

• 1 other identifier: 29BRC20.0233
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

ANCA-associated Vasculitis

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival of the disease

  Relapse-free survival of the disease

  Five years after diagnosis

Secondary Outcomes (10)

• death

  Five years after diagnosis

• Age

  Five years after diagnosis

• Sex

  Five years after diagnosis

• Physician assessment of disease activity

  Five years after diagnosis

• Patient assessment of disease activity

  Five years after diagnosis

Study Arms (1)

ANCA-associated vasculitis - patient library

OTHER

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

Interventions

Blood samples (80 mL) OTHER

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

ANCA-associated vasculitis - patient library

Fecal samples OTHER

Fecal samples at inclusion

ANCA-associated vasculitis - patient library

Urinary sample (20-40 mL) OTHER

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

ANCA-associated vasculitis - patient library

Questionnaires OTHER

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

ANCA-associated vasculitis - patient library

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest - Service de rhumatologie

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Divi CORNEC

CONTACT

(0)2 98 34 72 64; divi.cornec@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnosis and follow up of ANCA-associated vasculitis

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: May 6, 2022
• Study Start: October 27, 2022
• Primary Completion (Estimated): October 27, 2032
• Study Completion (Estimated): October 27, 2032
• Last Updated: August 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)