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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the plasma free GAGome MCED test | Indicative of any-type cancer vs. no cancer diagnosis | Within 365 days after the biosampling visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy to the putative cancer location (PCL) model among cases (confirmed cancer diagnosis) | Accuracy to the putative cancer location (PCL) model among cases (confirmed cancer diagnosis) | Within 365 days after the biosampling visit | 
| Sensitivity and specificity of the plasma free GAGome MCED test followed by low-dose computed tomography (LDCT) | Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT | Within 365 days after the biosampling visit | 
| Sensitivity and specificity of LDCT followed by plasma free GAGome MCED test | Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT | Within 365 days after the biosampling visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liquid biopsy, multi-cancer early detection, glycosaminoglycans