Clonal Hematopoiesis in Giant Cell Arteritis

Launched by ASST FATEBENEFRATELLI SACCO · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is examining a condition called Giant Cell Arteritis (GCA), which affects the blood vessels, particularly those in the head and neck. The main goal of the study is to find out if a phenomenon known as Clonal Hematopoiesis of Indeterminate Potential (CHIP) is related to how GCA develops and how patients respond to treatment. Researchers will look at blood samples from patients who are suspected of having GCA to see if CHIP is present and how it might influence the disease's symptoms and progression.

To participate in this trial, patients must be between the ages of 65 and 74 and have symptoms suggesting active GCA, as well as be able to provide consent for the study. They should also be able to undergo a temporal artery biopsy, a quick procedure to help confirm the diagnosis, within three hours of joining the study. Patients with certain infections, active cancers, or those on specific medications will not be eligible. Participants in this trial can expect thorough assessments, including blood tests and biopsies, to help researchers better understand the connection between CHIP and GCA. This study is not yet recruiting participants, but it aims to gather important information that could improve treatments for patients with GCA in the future.

Gender

ALL

Eligibility criteria

• 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 investigator as a contra-indication to eligibility.