Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Creation of a prospective cohort of EGPA-vasculitis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Creation of a prospective cohort of EGPA-vasculitis
时间窗: 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
时间窗: 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
次要结局
- Identification of comorbidities(5 years)
- Evaluation of results reported by patients(5 years)
- Identification of patterns of vasculitis(5 years)
- Identification of predictive and prognostic factors(5 years)
- Monitoring of the results reported by patients(5 years)