Lymph node biopsy study in ANCA-associated vasculitis
Research type
Research Study
Full title
A prospective observational pilot study of participants with ANCA-associated vasculitis to evaluate the feasibility of using percutaneous core needle biopsy examination of inguinal lymph nodes to investigate disease pathogenesis, response to therapy and relapse risk.
IRAS ID
211594
Contact name
David Jayne
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV), a rare autoimmune disease causing inflammation of blood vessels can result in organ failure and death. In AAV, drugs such as cyclophosphamide or rituximab in combination with high-dose steroids are used to reduce the inflammation caused by white blood cells (called lymphocytes). Even though this treatment is effective, it is associated with repeated disease flares (relapses) leading to organ damage and treatment-related side effects. The main challenges encountered in the management of patients are 1) to develop less harmful treatments 2) predict the risk of relapses early and 3) predict the response to treatment.
Lymph glands are important structures in the immune-system where self-attacking lymphocytes causing inflammation are produced. Treatment with cyclophosphamide/rituximab kills the disease-causing lymphocytes in the bloodstream. However, this process is incomplete and tissues such as lymph glands retain these cells and are likely to contribute to the risk of relapses. By studying the changes seen within lymph glands and bloodstream in patients with vasculitis, we may get a better understanding of the disease processes, be able to predict the risk of relapses and test the efficacy of treatments. This information may allow us to tailor the treatments according to patient’s need thereby reducing disease and treatment-related complications.
In order to understand the changes seen in the lymph glands, we plan to obtain tissue from the patients before and 3-4 months after the initiation of treatment and healthy volunteers. Groin lymph node biopsy can be done safely through the skin under ultrasound guidance. Samples obtained will be studied in depth using advanced research techniques. Similar studies in rheumatoid arthritis reported that this procedure is well tolerated. This pilot study in the first instance will inform us of the practicalities of this technique as a research tool.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0026
Date of REC Opinion
2 Feb 2017
REC opinion
Further Information Favourable Opinion