Screening programs in breast, prostate, colorectal and cervical cancer have resulted in significant reductions in mortality rates from these cancers. However, particularly lethal cancers like lung and kidney cancer have currently no approved tests for early detection - even in populations at high-risk of developing either cancer type such as adults with significant smoking history. Although medical imaging using for example low-dose computed tomography (LDCT) have the potential to simultaneously diagnose multiple cancer types such as lung and kidney cancer, these modalities are not practical, they do not capture any molecular information (hence limiting their sensitivity and specificity), and can be costly to implement. Liquid biopsies represent front-runner modalities for multi-cancer early detection (MCED) but virtually all of them rely on genomics biomarkers, typically circulating free DNA (cfDNA), which capture ~20% of lung cancers at stage I and <20% of kidney cancers at any stage. Pilot studies showed that free glycosaminoglycan profiles in plasma and urine, or free GAGomes, were promising noninvasive biomarkers of cancer metabolism that detected over a third of stage I cancers across 14 types, including lung and kidney cancers.
LEVANTIS-0093A (LEV93A) is a prospective cohort observational clinical study to validate the plasma free GAGome MCED test in adults at high risk of developing cancer (“high-risk adults”), specifically in 55–80-year-old adults with significant smoking history. LEV93A will use plasma biospecimens and corresponding patient data prospectively collected within the Yorkshire Lung Screening Trial (YLST) Biomarker sub-study, the the Yorkshire Lung Screening Trial (YLST), and the Yorkshire Kidney Screening Trial (YKST), all of which are sponsored by the University of Leeds and funded by the Yorkshire Cancer Research (award references: L403, L403B, L403C), in collaboration with the University of Manchester, the University of Leeds and Leeds Teaching Hospital Trust (LTHT).
LEVANTIS-0093A is registered at ClinicalTrials.gov (NCT05295017).