Prospective Longitudinal Cohort Study of Vasculitis Patients

Assistance Publique - Hôpitaux de Paris670 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

670

Conditions

Vasculitis

Interventions

Data collectionOTHER

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 collectionOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Service de médecine interne, Hôpital Cochin, AP-HP

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Creation of a prospective cohort of vasculitis

Vasco cohort : To create of a large prospective cohort of vasculitis patients to describe the presentation, therapeutic management, comorbidities and outcomes, based on the analysis of clinical, biological and immunological data

Time frame: 5 years

Creation of a prospective cohort of EGPA-vasculitis

EGPA -Vasco cohort : To create of a large prospective cohort of vasculitis patients to describe the presentation, therapeutic management and his efficacity, comorbidities and outcomes of EGPA, based on the analysis of clinical, biological and immunological data. The evaluation of the response to the treatment will be based, for all the different treatments, on the ability or not to reach a prednisone dose of 4.0 mg or less, at any time (binary criterion)). The treatments will be used at the discretion of the referring physician in charge of the pathology, according to what is recommended in the National Diagnostic and Care Protocol (PNDS) in force.

Time frame: 5 years

Secondary Outcomes

Identification of patterns of vasculitis

To identify possible relationships between clinical patterns of vasculitis and response to treatment, risk of glucocorticoids dependence, survival, etc.

Time frame: 5 years

Identification of comorbidities

To identify comorbidities and the impact on therapeutic management and patient outcomes

Time frame: 5 years

Identification of predictive and prognostic factors

To identify radiological, histological, pharmacological, genetic, molecular and immunological predictive and prognostic markers.

Time frame: 5 years

Evaluation of results reported by patients

Central Contacts

Benjamin Terrier, PhD

CONTACT

+33 1 58 41 14 61 benjamin.terrier@aphp.fr

Marie BENHAMMANI-GODARD

CONTACT

00 33 1 54 41 12 11 marie.godard@aphp.fr

Data from ClinicalTrials.gov

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