About this trial
The goal of this clinical trial is to verify whether CHIP is correlated with the clinical, instrumental, and histological characteristics of GCA, and to characterize the pathogenetic effects of clonal hemopoiesis on vasculitis. The main objective of this study is to verify if clonal hematopoiesis of indeterminate potential (CHIP) affects GCA manifestations, course/response to therapies, and pathogenesis.
Patients who are going to be diagnosed with GCA and for which a fast track is available for a rapid diagnostic work-up including pre-treatment temporal artery biopsy. Patients with CHIP will be identified and characterized by using whole exome sequencing from the peripheral blood samples. The presence and characteristics of CHIP will be correlated with baseline clinical, instrumental, and histologic GCA features.
Eligibility criteria
Qualifiers
Patients with suspected active GCA entering into a fast-track work-up and healthy matched controls.
Capability of providing valid consent to study enrollment.
Possibility of performing temporal artery biopsy within three hours from enrollment.
Disqualifiers
Active concurrent viral, fungal or bacterial infections (including active/latent tuberculosis treated for less than 4 weeks, HIV and Hepatitis B/C virus (HBV/HCV) infections.
Concurrent systemic inflammation not attributable to GCA (inflammatory diseases in treatment-free remission are accepted).
Use of other immunosuppressive agents in the last 3 months.
Use of systemic steroids (any dose in the last week, > 15 mg/die of prednisone equivalent in the last month).
Trial design
Treatments tested in this trial
- Temporal arterial biopsy
- Whole exome sequencing
- Single cell transcriptomics