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

Elypta

Status: Active, not recruiting

Conditions: Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT05295017

GR 22-016

Details and patient eligibility

About

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.

Enrollment: 1,235 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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