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

NCT05295017 | Active Not Recruiting

• 1 other identifier: GR 22-016
• Study Type: observational
• Target: 1,235
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cancer

Keywords

liquid biopsy; multi-cancer early detection; glycosaminoglycans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

  Within 365 days after the biosampling visit

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

  Within 365 days after the biosampling visit

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Adults aged 55-80 years old
• Significant smoking history, defined as current or ex-smokers and any of the following criteria:
• 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

You may not qualify if:

• Deemed medically unfit for sample collection
• Contraindication for study procedures or sampling
• Not consenting to participate to YKST trial

Sponsors & Collaborators

• Elypta: lead

Study Sites (1)

Leads Teaching Hospitals Trust

Leeds, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Prospectively collected blood samples sourced from patients enrolled in study

MeSH Terms

Conditions

Neoplasms

Study Officials

• Francesco Gatto, PhD

  Elypta AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 24, 2022
• Study Start: March 14, 2022
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

GB (1)