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NCT Number: NCT05295017

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Leads Teaching Hospitals Trust

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity and specificity of the plasma free GAGome MCED test

    Time frame: Within 365 days after the biosampling visit

    Indicative of any-type cancer vs. no cancer diagnosis

Secondary outcomes

  1. Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)

    Time frame: Within 365 days after the biosampling visit

    Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)

  2. Sensitivity and specificity of the plasma free GAGome MCED test followed by low-dose computed tomography (LDCT)

    Time frame: Within 365 days after the biosampling visit

    Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT

  3. Sensitivity and specificity of LDCT followed by plasma free GAGome MCED test

    Time frame: Within 365 days after the biosampling visit

    Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT

Sponsors and collaborators

Lead sponsor

Elypta

Industry

Registry information

Acronym: LEV93A

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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