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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
* Solid or hematologic malignancies (active or with less than 6 months free of disease or antiblastic chemotherapy (hormone therapy is allowed).
* Previous solid or hematopoietic stem cell transplantation (corneal transplants are allowed).
* Any systemic immunosuppressive or steroidal therapy.
* Chronic renal failure with Glomerular Filtration Rate (GFR) \< 45 ml/min \*1.73 m2.
* Moderate-severe liver failure (Child-Pugh B or C), hepatitis in stages of activity.
* Diabetes mellitus.
* Heart failure with New York Heart Association score (NYHA) \>=2.
* Severe hypoproteinemia/malnutrition.
* Chronic respiratory failure requiring O2 therapy or ventilation therapy at home.
* Any other condition judged by the local investigato…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of GCA with M-CHIP-driven by DNMT3A mutations