Evaluation of fine needle aspiration samples in podoconiosis.
Research type
Research Study
Full title
Use of fine needle aspiration (FNA) of lymph node samples to evaluate lymph nodes in patients with podoconiosis and local controls.
IRAS ID
189273
Contact name
Gail Davey
Contact email
Sponsor organisation
University of Sussex
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Best evidence to date suggests that podoconiosis (endemic non-filarial elephantiasis) is the result of an abnormal inflammatory reaction to mineral particles that penetrate the skin and accumulate in the lower leg. The lymph system suffers inflammatory damage, and no longer works efficiently, resulting in collection of lymph fluid (lymphoedema) in the feet and lower legs. The evidence for the disease process dates from a range of studies carried out in the 1970s and 1980s by Dr Ernest Price, a leprosy specialist living in Ethiopia.
We plan to use fine needle aspiration (FNA) to examine palpable lymph nodes from adult patients with and without podoconiosis, and at a range of disease stages. Our hypothesis is that lymphoid hyperplasia, sinus histiocytosis with accumulation of macrophages containing particulate matter and granulomatous inflammation will develop and evolve during progression to later stages of disease.
A qualitative morphologic study will be conducted among untreated adult patients and controls with no evidence of lymphoedema. Ten to fifteen patients at stages 1, 2, 3 and 4/5, and 10-15 controls will be recruited through the International Orthodox Christian Charities (IOCC) podoconiosis project in Northern Ethiopia. It is important to include people without podoconiosis because earlier studies demonstrated the presence of mineral within the tissues of both affected and unaffected people living on irritant soils.
Having first checked patient consent, Dr Worku Mekonnen, Consultant Surgeon at Debre Markos Hospital will collect a fine needle aspirate (FNA) sample into a methanol-water transport medium. These will be shipped according to a Material Transfer Agreement drawn up between the University of Sussex and Debre Markos Hospital. The samples will be registered under the Human Tissues Act on arrival. Dr Williams and Dawn Carrington will stain, examine and evaluate the cellular components of the enlarged lymph nodes at Brighton and Sussex University Hospitals Department of Cellular Pathology, using standard operating procedures. Immunocytochemistry and Scanning Electron Microscopy will be performed if the preservation of the samples permits.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0798
Date of REC Opinion
6 Oct 2015
REC opinion
Favourable Opinion