Prospective Longitudinal Cohort Study of Vasculitis Patients

  • STATUS
    Recruiting
  • End date
    Jul 5, 2030
  • participants needed
    300
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 19 February 2024
vasculitis

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.

Description

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.

Details
Condition Vasculitis, Vascular Diseases, Vascular Diseases
Age 18-100 years
Treatment data collection, Biological samples and data collection
Clinical Study IdentifierNCT04413331
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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