Prospective Longitudinal Cohort Study of Vasculitis Patients

NCT04413331 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2020-07-02

Last updated

2025-09-12

Condition(s) studied

Vasculitis

Investigational drug(s) / intervention(s)

Data collectionBiological samples and data collection

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

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Creation of a prospective cohort of vasculitis — 5 years
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
Creation of a prospective cohort of EGPA-vasculitis — 5 years
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.

Trial sites (1)

Facility	City	Region	Status
Service de médecine interne, Hôpital Cochin, AP-HP	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04413331 on ClinicalTrials.gov ↗ ← All trials in France