SysteMic vAsculitis pRognosis and ouTcome

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Study ID
NCT07586137
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Feb 8, 2022
Status verified
May 2026
Primary completion
Jun 15, 2028
Completion
Jun 15, 2030

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

mortality [ Time Frame: 10 years ]

Central Contacts

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