Prospective Longitudinal Cohort Study of Vasculitis Patients

Recruiting

• Conditions: Vasculitis
• Interventions: Other: Data collection; Other: Biological samples and data collection

• Registration Number: NCT04413331
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Study Start: 2020-07-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2027-07
• Study Completion: 2032-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 670

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vasculitis	Biological samples and data collection	Those with systemic vasculitis
EGPA vasculitis	Data collection	-
Vasculitis	Data collection	Those with systemic vasculitis
EGPA vasculitis	Biological samples and data collection	-

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
Identification of comorbidities	5 years	To identify comorbidities and the impact on therapeutic management and patient outcomes
Evaluation of results reported by patients	5 years	Evaluate the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)
Identification of patterns of vasculitis	5 years	To identify possible relationships between clinical patterns of vasculitis and response to treatment, risk of glucocorticoids dependence, survival, etc.
Identification of predictive and prognostic factors	5 years	To identify radiological, histological, pharmacological, genetic, molecular and immunological predictive and prognostic markers.
Monitoring of the results reported by patients	5 years	Monitor the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)

Trial Locations

Locations (1)

Service de médecine interne, Hôpital Cochin, AP-HP; 🇫🇷 Paris, France