LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)

NCT05295017 · tracked via the Priya Life Science UK tracker

Sponsor

Elypta

Phase

Observational

Started

2022-03-14

Last updated

2024-09-19

Condition(s) studied

Cancer

Study summary

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 collected within the Yorkshire Lung Screening Trial Biomarker sub-study and corresponding participant data prospectively collected within 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 Yorkshire Cancer Research (Award references: L403, L403B L403C), in collaboration with the University of Leeds, with the University of Manchester and with the Leeds Teaching Hospitals.

Eligibility

Sex

ALL

Min age

55 Years

Max age

80 Years

Healthy volunteers

Accepted

Inclusion Criteria * Adults aged 55-80 years old * Significant smoking history, defined as current or ex-smokers and any of the following criteria: * 30 pack year history of smoking and current smoker or quit within the last 15 years (USPSTF criteria). * Lung cancer risk of ≥1.51% over 6 years as calculated by the PLCOM2012 score * Lung cancer risk of ≥5% over 5 years as calculated by the LLPv2. Score * Consenting to participate to both YLST and YLST Biomarker trials * Able to donate a blood sample Exclusion Criteria * Deemed medically unfit for sample collection * Contraindication for study procedures or sampling * Not consenting to participate to YKST trial

Primary outcome measure(s)

Sensitivity and specificity of the plasma free GAGome MCED test — Within 365 days after the biosampling visit
Indicative of any-type cancer vs. no cancer diagnosis

Trial sites (1)

Facility	City	Region	Status
Leads Teaching Hospitals Trust	Leeds	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05295017 on ClinicalTrials.gov ↗ ← All trials in the UK