Non-invasive, Multi-modal Inflammatory Biomarker Discovery for Systemic Inflammation (NOVA Study): A Feasibility Study Protocol (Under Review)

Abstract

Prolonged systemic inflammation is recognized as a major contributor to the development of various chronic inflammatory diseases. Daily measurements of inflammatory biomarkers can significantly improve disease monitoring of systemic inflammation, thus contributing to reducing the burden on patients and the entire healthcare system. There exists, however, no scalable, cost-efficient, and non-invasive biomarker for remote assessment of systemic inflammation. To this end, we propose a novel multi-modal, non-invasive approach for measuring inflammatory biomarkers. We aim to evaluate the relationship between the levels of inflammatory biomarkers in serum (gold standard) and those measured non-invasively in urine, sweat, saliva, exhaled breath, stool, and core body temperature in patients with systemic inflammation. This study is a single-center, cross-sectional study and includes a total of 20 participants (10 systemic inflammation patients and 10 control patients). Eligible participants provide serum, urine, sweat, saliva, exhaled breath, and stool samples for biomarker analyses. Core body temperature is measured using a sensor. The primary endpoint is the level of C-reactive protein. The secondary endpoints are interleukin (IL)-1β, IL-6, IL-8, IL-10, and tumor necrosis factor-α levels. The tertiary endpoints are fractional exhaled nitric oxide, calprotectin, and core body temperature. Shapiro-Wilk test will be used to evaluate the normality of the distribution in each variable. We will perform the two-tailed t-test (or Wilcoxon rank-sum test, if non-normal) to compare the levels of inflammatory biomarkers between patients with systemic inflammations and controls. Pearson and Spearman correlation coefficients will assess the relationship between non-invasive methods and the serum. A total of 20 participants participated in the study measurements between February and September 2023. Participants were on average 52.8 (range 24-82, SD 14.4) years of age, and 70% (n=14) of them were women. The analysis results reporting findings are expected to be published in the fall of 2024. This is a proof-of-concept study evaluating the feasibility of non-invasive, multi-modal inflammatory biomarker discovery. Promising results could lead to the creation of non-invasive and digital biomarkers for systemic inflammation, which could be implemented for a larger, prospective, longitudinal cohort study.

Jinjoo Shim

Digital Health Data Scientist

My research interests is to advance digital healthcare through AI/ML and data science.