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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05295017

Acronym

LEV93A

Enrollment

1235

Registered

2022-03-24

Start date

2022-03-14

Completion date

2026-03-31

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

liquid biopsy, multi-cancer early detection, glycosaminoglycans

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

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

Countries

United Kingdom

Outcome results