Prospective clinical validation of novel serum biomarker test for the identification of patients at risk of brain tumour.


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Paul Brennan1,Holly Butler2,Mark Hegarty3,Ben Smith2,David Palmer2,Michael Jenkinson4,Matt Baker5

1university of edinburgh,2University of Strathclyde,3Clin Spex Dx Ltd,4University of Liverpool,5university of Strathclyde

Abstract

Background

The most common symptoms of patients with brain tumours are non-specific. More than 60% of patients are diagnosed in Emergency Departments; many will have previously attended primary care. We investigated whether our novel serum biomarker test could identify which patients thought to be at risk of a brain tumour based on their symptoms should be prioritized for brain imaging. The test uses infrared light to provide a spectral signature from human serum, and pattern recognition algorithms to ‘learn’ which samples are indicative of brain tumour. We have previously reported sensitivity and specificity of the test based on archival samples.

Method

Our regional clinical neurosciences unit provides a referral pathway for primary care doctors to directly access rapid brain imaging. We obtained ethical approval (15/ES/0094) to seek consented serum blood samples prior to brain imaging. Infrared spectroscopic examination was performed. The data set was supplemented with consented samples from patients with known brain tumours taken prior to surgery. Spectroscopic examination was blinded to the brain imaging results.

Results

We have recruited 400 patients; over 40 tumours. We achieved sensitivities and specificities for a brain tumour of 82 and 84%, respectively.

Conclusion

This rapid screening test can revolutionise triage of patients in primary care suspected of having a brain tumour, helping prioritise the most at-risk for rapid imaging.