Investigating the Feasibility of Harmonising PTH Measurement
Research type
Research Study
Full title
Investigating the Feasibility of Harmonising Parathyroid Hormone Measurement
IRAS ID
369590
Contact name
Chris Hughes
Contact email
Sponsor organisation
East Lancashire Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Calcium and phosphate are minerals that are important to the functioning of bones, muscles, and nerves in the body. The level of calcium and phosphate in blood are primarily regulated by a hormone called Parathyroid Hormone (PTH). Measuring the PTH in blood is therefore crucial to investigate and monitor patients that have medical conditions affecting the level of calcium and phosphate. However, if you were to measure PTH in one laboratory, and take that same blood sample and measure it in another laboratory, the PTH result is likely to be significantly different. This represents a clinical problem, particularly in patients with kidney conditions who sometimes have their bloods measured at different laboratories. The variation in results between different automated machines that laboratories use for measuring PTH has the potential to cause confusion and to be incorrectly interpreted as a significant change in PTH which could impact treatment decisions. Furthermore, with patients now able to access their own results via the NHS app, differences in their PTH results could cause confusion and anxiety.
This first aim of this project is to investigate the variation between the automated machines used routinely to measure PTH throughout the UK. A variety of patients will be included, including those with normal kidney function, those with mild and severe kidney dysfunction, and patients who have a medical condition called primary hyperparathyroidism. We then aim to develop a novel method for measuring PTH that uses a technology that is generally accepted to provide a more accurate method of quantifying hormones like PTH. The difference in results between this more accurate method and the other methods used routinely will be calculated, and equations will be derived to mathematically describe any differences between methods. We then aim to assess whether these equations can improve the comparability of PTH results
REC name
London - Bloomsbury Research Ethics Committee
REC reference
26/PR/0776
Date of REC Opinion
9 Jul 2026
REC opinion
Favourable Opinion