Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Elypta

Conditions:

Cancer

Eligibility:

All Genders

55-80 years

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 14 2022

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2026

    Estimated Enrollment :

    1235 Patients enrolled

    Trial Details

    Trial ID

    NCT05295017

    Start Date

    March 14 2022

    End Date

    March 1 2026

    Last Update

    September 19 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Leads Teaching Hospitals Trust

    Leeds, United Kingdom