Prospective Longitudinal Cohort Study of Vasculitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-02

Study Completion Date

2032-07-31

Brief Summary

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VASCO is a prospective observational cohort study which aim to describe the presentation, comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of the clinical, biological and immunological data.

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Detailed Description

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Vasculitis is a group of disorders characterized by the inflammation of blood vessels, leading to an alteration of the vascular wall. The classification of vasculitides has evolved considerably over the last few decades.

In 1990, the American College of Rheumatology established a classification of the main systemic vasculitides based on clinical, biological and histological criteria. In 1994, the Chapel Hill nomenclature has been established as the reference classification system of vasculitides and vasculitides were classified according to the size of the affected vessels. The Chapel Hill nomenclature was revised in 2012, thus enabling to integrate new vasculitides and diagnostic tools.

It is proposed here to conduct a non-interventional cohort study of the different forms of vasculitis, as defined in the Chapel Hill nomenclature. By collecting data from a large number of patients followed prospectively, our objective is to describe the clinical patterns of these diseases, the presentation, management, comorbidities and outcomes, and to evaluate their possible association with some immunological, genetic and molecular parameters.

Conditions

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Vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vasculitis

Those with systemic vasculitis

Data collection

Intervention Type OTHER

Medical data collection at M0, M3, M6, M9 and M12 then every 6 months until M60 and at each vascularitis relapse

Biological samples and data collection

Intervention Type OTHER

Biological samples at M0, M6, M12, M24 and at each relapse until M60

EGPA vasculitis

Data collection

Intervention Type OTHER

Medical data collection at M0, M3, M6, M9 and M12 then every 6 months until M60 and at each vascularitis relapse

Biological samples and data collection

Intervention Type OTHER

Biological samples at M0, M6, M12, M24 and at each relapse until M60

Interventions

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Data collection

Medical data collection at M0, M3, M6, M9 and M12 then every 6 months until M60 and at each vascularitis relapse

Intervention Type OTHER

Biological samples and data collection

Biological samples at M0, M6, M12, M24 and at each relapse until M60

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age over 18 years),
* Patients with vasculitis, as defined in the Chapel Hill International Nomenclature as revised in 2012,
* Patients included at an active phase of the disease, either the initial flare or a relapse,
* Patients who have been informed and have signed the consent
* Pregnant and breastfeeding women may be included in the study,
* Affiliated to a social security system (beneficiary or entitled person).

Exclusion Criteria

* Refusal of consent or inability to obtain consent,
* A patient who is insane or not entitled, for psychiatric reasons or intellectual impairment, to receive information about the protocol and to give informed consent,
* Patient under guardianship / curators
* Patient on state medical assistance (AME)
* Hemoglobin less than 7 g/dl at the time of sampling,
* Hemoglobin level less than 9 g/dl at the time of sampling if the patient has respiratory or cardiovascular disease,
* Patient weighs less than 18 kg.
* Parallel participation in an interventional protocol is permitted.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No