Evaluating the VOCORDER device for early disease detection through breath analysis: study protocol for a two-phase clinical study

Introduction The survival rate of patients with life-threatening diseases primarily depends on the speed of diagnosis. Too often, diseases are detected only after symptoms appear, which usually occurs at later stages of a disease when available treatments may be less effective.

Current detection techniques primarily depend on identifying metabolites in biofluids such as blood and urine. The analysis of these fluids is typically performed in laboratories, resulting in lengthy waiting times for patients to receive their results.

In severe cases, invasive biopsies and radiative methods are used to diagnose conditions such as cancer. These biopsies can cause distress for patients who are already experiencing significant emotional or physical stress, while imaging techniques involving ionising radiation may pose additional health risks.

Additionally, these methods can be costly. In recent years, exhaled breath has become a biofluid matrix of interest for disease detection, allowing for the identification of volatile organic compounds (VOCs) or VOC profiles associated with specific conditions.