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

Sponsor

Elypta (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05295017

Collaborator

(none)

1,256

Enrollment

Location

35.6

Anticipated Duration (Months)

35.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

1256 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 14, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity of the plasma free GAGome MCED test [Within 365 days after the biosampling visit]
Indicative of any-type cancer vs. no cancer diagnosis

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leads Teaching Hospitals Trust	Leeds		United Kingdom

Sponsors and Collaborators

Elypta

Investigators

Principal Investigator: Francesco Gatto, PhD, Elypta AB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elypta

ClinicalTrials.gov Identifier:

NCT05295017

Other Study ID Numbers:

GR 22-016

First Posted:

Mar 24, 2022

Last Update Posted:

Mar 24, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elypta

liquid biopsy

multi-cancer early detection

glycosaminoglycans

Study Results

No Results Posted as of Mar 24, 2022