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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05295017
Other study ID # GR 22-016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 14, 2022
Est. completion date March 2025

Study information

Verified date May 2023
Source Elypta
Contact Francesco Gatto, PhD
Phone +46 (0)8 520 27 885
Email info@elypta.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1256
Est. completion date March 2025
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Leads Teaching Hospitals Trust Leeds

Sponsors (1)

Lead Sponsor Collaborator
Elypta

Country where clinical trial is conducted

United Kingdom, 

Outcome

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