Document Type
Journal Article
Publication Title
BMJ Open
Volume
11
Issue
9
Publisher
BMJ Publishing Group
School
Centre for Integrative Metabolomics and Computational Biology / School of Science
RAS ID
39705
Funders
National Health and Medical Research Council Western Australia Department of Health Improving Health Outcomes in the Tropical North
Grant Number
NHMRC Numbers : 1147531, 1142011, 1131932
Grant Link
http://purl.org/au-research/grants/nhmrc/1147531
Abstract
Introduction:
The absence of a diagnostic test for acute rheumatic fever (ARF) is a major impediment in managing this serious childhood condition. ARF is an autoimmune condition triggered by infection with group A Streptococcus. It is the precursor to rheumatic heart disease (RHD), a leading cause of health inequity and premature mortality for Indigenous peoples of Australia, New Zealand and internationally.
Methods and analysis:
Searching for a Technology-Driven Acute Rheumatic Fever Test' (START) is a biomarker discovery study that aims to detect and test a biomarker signature that distinguishes ARF cases from non-ARF, and use systems biology and serology to better understand ARF pathogenesis. Eligible participants with ARF diagnosed by an expert clinical panel according to the 2015 Revised Jones Criteria, aged 5-30 years, will be recruited from three hospitals in Australia and New Zealand. Age, sex and ethnicity-matched individuals who are healthy or have non-ARF acute diagnoses or RHD, will be recruited as controls. In the discovery cohort, blood samples collected at baseline, and during convalescence in a subset, will be interrogated by comprehensive profiling to generate possible diagnostic biomarker signatures. A biomarker validation cohort will subsequently be used to test promising combinations of biomarkers. By defining the first biomarker signatures able to discriminate between ARF and other clinical conditions, the START study has the potential to transform the approach to ARF diagnosis and RHD prevention.
Ethics and dissemination:
The study has approval from the Northern Territory Department of Health and Menzies School of Health Research ethics committee and the New Zealand Health and Disability Ethics Committee. It will be conducted according to ethical standards for research involving Indigenous Australians and New Zealand Mā ori and Pacific Peoples. Indigenous investigators and governance groups will provide oversight of study processes and advise on cultural matters.
DOI
10.1136/bmjopen-2021-053720
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License
Comments
Ralph, A. P., Webb, R., Moreland, N. J., McGregor, R., Bosco, A., Broadhurst, D., . . . Carapetis, J. R. (2021). Searching for a technology-driven acute rheumatic fever test: The START study protocol. BMJ Open, 11(9), Article e053720.
https://doi.org/10.1136/bmjopen-2021-053720