Cryoproteins and their clinical significance
Research type
Research Study
Full title
Improving the clinical relevance of cryoprotein analysis: investigation into the correlation of cryoglobulin precipitation temperatures and cryofibrinogen laboratory features with clinical symptoms in patients with suspected cryoproteinaemia.
IRAS ID
356559
Contact name
Rachel Wheeler
Contact email
Sponsor organisation
South West London Pathology - St Georges NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Cryoproteins are proteins found in patients blood which precipitate at temperatures below 37c. They include cryofibrinogen and three other types of immunoglobulin based on their type, clonality, and other laboratory results (complement and rheumatoid factor concentrations).
Their different types are associated with different diseases, which range from cancers, autoimmune diseases and infections. Additional symptoms can be caused by cryoglobulins by triggering inflammation in small blood vessels. These can affect the kidneys, lungs, or skin, and can precipitate in blood vessels, reducing blood flow, when the temperature is low enough.
We aim to develop an assay to determine the temperature that a patient's cryoglobulin will precipitate in their blood sample. We will then determine if there is a link between a person's cryoglobulin precipitation temperature and their clinical outcomes.
Additionally, cryofibrinogens can sometimes be caused by sample degradation. We have noticed that a confirmatory testing to identify the precipitate as cryofibrinogen, known as immunofixation, gives us different patterns. We think that these patterns may relate to whether the cryofibrinogen result could be due to degradation, due to certain medications, or be a sign of disease. We aim to investigate old results of patients to see if their immunofixation patterns correlate with their clinical outcomes.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
26/EM/0058
Date of REC Opinion
12 Mar 2026
REC opinion
Favourable Opinion