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

Cancer Clinical Trial

— LEV93A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295017
• Other study ID #: GR 22-016
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cancer

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