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临床试验/NCT07586137
NCT07586137招募中不适用

SysteMic vAsculitis pRognosis and ouTcome

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
mortality

研究概览

简要总结

This will be a pragmatic programme of research, consecutively recruiting all-comers who have been referred to secondary care for assessment of suspected Systemic Vasculitis (SV) into a longitudinal inception cohort. For patients with a pre-existing diagnosis, data on the disease onset will be collected retrospectively. All patients followed prospectively from the time of inclusion into the study will be followed at intervals corresponding to the recommended standard of care. We will invite participants to consent to the whole programme of research in order to allow their samples, as well as their data, to be used for in multiple related projects that have the same common aim. In this long-term inception cohort we will collect data on clinical features, prognostic factors and outcomes of patients diagnosed with a SV over the course of 10 years. We will examine the role of clinical features, imaging and biomarkers in the characterisation of the disease with a particular focus on risk stratification. This will be closely integrated with the other objectives of the study: analysing clinical features, imaging characteristics, outcomes, rates and predictors of relapses and remission, in order to obtain a prognostic stratification of the patients and to capture a cohort of patients at high risk of relapse and poor outcome who could inform on the potential use of more intensive treatment strategies to be assessed in future studies.

The SMART programme will be guided by three main overarching themes:

  1. "Theme 1": The identification of risk factors associated with poor outcome, relapse and failure to achieve remission
  2. "Theme 2": The assessment of different tools to assess risk factors (imaging, biomarkers, clinical features)
  3. "Theme 3": The analysis of cohorts of SV patients in observational studies The overarching aims of the study will be overlapping throughout the different investigations outlined in the following paragraphs analyzing: outcomes (including treatment-derived damage), monitoring and relapse, and remission in SV.

We aim to follow patients up over a total of 10 years, in order to provide the richest and most complete set of data that has ever been collected for this patient group.

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

入选标准

  • Willing and able to give informed consent
  • clinical suspicion or a confirmed diagnosis of Systemic Vasculitis

排除标准

  • Inability to give informed consent

结局指标

主要结局

mortality

时间窗: 10 years

vasculitis complications

时间窗: 10 years

rate of relapse

时间窗: 10 years

次要结局

未报告次要终点

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandra Milanesi

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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