LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to validate the diagnostic performance of free GAGome-based tests for multi-cancer early detection (MCED) in adults asymptomatic for cancer and with no recent history of cancer.
Multi-cancer early detection (MCED) could prevent 26% of all cancer-related deaths - an effect larger than averting all deaths from breast cancer alone. However, a societal program to implement MCED requires a practical, noninvasive, and affordable diagnostic modality that is sensitive and specific to all forms of cancers. Liquid biopsies represent front-runner modalities to this end but virtually all of them rely on genomics biomarkers, typically circulating free DNA (cfDNA), which capture \<20% of cancers in stage I. In addition, they miss certain cancer types that shed little cfDNA, like brain or genitourinary tumors. Pilot studies show 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 brain and genitourinary tumors. LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to develop free GAGome-based tests for multi-cancer early detection in adults asymptomatic for cancer and with no recent history of cancer (Sub-Study 1) and to validate their diagnostic performance in the target population (Sub-Study 2). LEV87A uses retrospectively collected biospecimens from one or more population-based biobanks representative of the target population.
Study Type
OBSERVATIONAL
Enrollment
9,170
The combined free GAGome MCED test aggregates measurements of plasma and urine GAGomes (the exhaustive human glycosaminoglycan profile) into a diagnostic score, the combined free GAGome MCED score. The measurements are performed using MIRAM MCED Kits (Elypta AB) and the scores are computed using Elypta SKY Software (Elypta AB)
Elypta AB
Stockholm, Sweden
RECRUITINGSensitivity and specificity of the combined free GAGome MCED test
Indicative of any-type cancer vs. no cancer diagnosis
Time frame: Within 365 days after the baseline visit
Sensitivity and specificity of the plasma free GAGome MCED test
Indicative of any-type cancer vs. no cancer diagnosis
Time frame: Within 365 days after the baseline visit
Sensitivity and specificity of the urine free GAGome MCED test
Indicative of any-type cancer vs. no cancer diagnosis
Time frame: Within 365 days after the baseline visit
Accuracy to the "putative cancer location" (PCL) model in the case (cancer) arm
Accuracy to the "putative cancer location" (PCL) model in the case (cancer) arm
Time frame: Within 365 days after the baseline visit
Overall survival (OS) in the case (cancer) arm
Overall survival (OS) in the case (cancer) arm
Time frame: From baseline visit until the date of death from any cause, assessed up to 15 years
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