BioAmyloid
Research type
Research Study
Full title
A non-interventional clinicopathological study to investigate pathogenesis and enhance clinical management of patients with amyloidosis and related disorders
IRAS ID
256590
Contact name
Julian Gillmore
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
20 years, 0 months, 0 days
Research summary
Systemic amyloidosis is a group of rare, progressive and usually fatal disorders caused by the 'clumping' of abnormal proteins in organs throughout the body. Clinical diagnosis is very challenging since symptoms are non-specific; many patients experience significant diagnostic delay which negatively impacts survival. There is huge need to develop more sensitive, specific and accurate diagnostic and monitoring techniques, and also to understand how the build-up of amyloid protein impairs vital organ function. The National Amyloidosis Centre, established at the Royal Free Hospital in 1999, provides the only specialist NHS service for patients with amyloidosis, including a comprehensive series of nuclear medicine, CT and MRI imaging, histological, genetic, proteomic, blood and urine tests. The centre has a long track record of clinical innovation, both in refining existing tests and developing new ones. The research proposal here is to use routinely obtained clinical samples and routine clinical data to improve: (1) the diagnosis of amyloidosis and confirmation of its type; (2) the understanding of how amyloid deposition causes organ dysfunction; (3) physicians’ ability to assess prognosis and stage disease; (4) the assessment of response to treatment; and (5) understanding of susceptibility to amyloid and amyloidosis. Patients will undergo routine, standard-of-care tests appropriate to their diagnosis or suspected diagnosis. All patients attending the centre will be invited to participate and will remain in the study until end of life, are discharged, or withdraw consent.
REC name
London - Surrey Research Ethics Committee
REC reference
21/PR/0620
Date of REC Opinion
16 Jun 2021
REC opinion
Favourable Opinion