Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04413331

Prospective Longitudinal Cohort Study of Vasculitis Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de médecine interne, Hôpital Cochin, AP-HP

Paris, 75014, France

Location status: Recruiting

Location contact

Benjamin Terrier, PhD

CONTACT

[email protected]

+33 1 58 41 14 61

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

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

Other

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

Primary outcomes

  1. Creation of a prospective cohort of vasculitis

    Time frame: 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

  2. Creation of a prospective cohort of EGPA-vasculitis

    Time frame: 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.

Secondary outcomes

  1. Identification of patterns of vasculitis

    Time frame: 5 years

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

  2. Identification of comorbidities

    Time frame: 5 years

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

  3. Identification of predictive and prognostic factors

    Time frame: 5 years

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

  4. Evaluation of results reported by patients

    Time frame: 5 years

    Evaluate the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)

  5. Monitoring of the results reported by patients

    Time frame: 5 years

    Monitor the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Terrier, PhD

CONTACT

[email protected]

+33 1 58 41 14 61

Marie BENHAMMANI-GODARD

CONTACT

[email protected]

00 33 1 54 41 12 11

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage

Acronym: VASCO

Important dates

Study start
2020
Primary completion
2027
Study completion
2032
First posted
Jun 2, 2020
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.