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

May 10, 2023 updated by: Elypta

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francesco Gatto, PhD
  • Phone Number: +46 (0)8 520 27 885
  • Email: info@elypta.com

Study Locations

  • United Kingdom
      • Leeds, United Kingdom
        • Recruiting
        • Leads Teaching Hospitals Trust
        • Contact:
          • Francesco Gatto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adults between 55 and 80 years old with significant smoking history ("high-risk adults").

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Within 365 days after the biosampling visit
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)
Time Frame: Within 365 days after the biosampling visit
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
Time Frame: Within 365 days after the biosampling visit
Indicative of any-type cancer vs. no cancer diagnosis in combination with LDCT
Within 365 days after the biosampling visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elypta

Investigators

  • Principal Investigator: Francesco Gatto, PhD, Elypta AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GR 22-016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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