Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
ID05364892

Biocollection of Patients With ANCA Associated Vasculitis Diagnosed Within the CERAINO Autoimmune Disease Reference Center, Part of the Global BRAISE Project

Led by University Hospital, Brest · Updated on 2024-08-07

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying ANCA-associated vasculitis, a group of rare and serious autoimmune diseases including granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis. The goal is to understand the disease better by collecting standardized data over several years, focusing mainly on identifying predictors of relapse and other complications like mortality, infections, cardiovascular issues, and cancer to improve patient care. Participants with ANCA-associated vasculitis will be part of a single study group undergoing various sample collections and assessments. These include blood samples, fecal samples, and urinary samples taken at the start, annually for five years, and during any relapse or treatment change. Questionnaires will also be completed at these times to gather patient-reported information. During the study, participants will be monitored for disease relapse and other health outcomes over five years. Researchers will use tools like the Birmingham Vasculitis Activity Score and Vasculitis Damage Index to assess disease activity and damage, alongside patient and physician evaluations. Safety and treatment effects, including the impact of glucocorticoids, will be tracked, with study visits involving sample collection and questionnaires to help understand disease progression and patient health over time.

CONDITIONS

Brief Title

Biocollection of Patients With ANCA Associated Vasculitis

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older with no upper age limit
  • Patients assessed at the reference centre for rare autoimmune diseases at the CHRU in Brest
  • Diagnosis of ANCA-associated vasculitis made by the treating physician according to Chapel-Hill Consensus Conference definitions
  • Affiliated with Social Security
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Minors
  • Unable to provide consent
  • Refusal to participate in research
  • Under legal protection (tutelage, curatorship)
  • Pregnant or lactating women
  • Hemoglobin level below 7 g/dL

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At inclusion

Participants provide blood, fecal, and urinary samples, and complete questionnaires at inclusion to assess disease status and collect baseline data.

1 visit (in-person)

Long-term Monitoring

Duration - 5 years

Participants provide blood and urinary samples, and complete questionnaires once a year for 5 years and additionally if they experience a relapse or change of treatment to monitor disease progression and treatment effects.

Annual visits and additional visits if relapse or treatment change occur

Trial Site Locations

Total: 1 location

1

CHRU de Brest - Service de rhumatologie

Brest, France, 29200

Actively Recruiting

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Research Team

D

Divi CORNEC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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