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Active Not RecruitingNCT04968548

Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
5,000 (estimated)
Sponsor
Nucleix Ltd. · Industry
Sex
All
Age
50 Years – 80 Years
Healthy volunteers

Summary

This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.

Detailed description

This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study aims to collect blood and clinical data from subjects undergoing Low Dose CT (LDCT) for lung cancer screening and subjects with confirmed lung cancer.

Conditions

Interventions

TypeNameDescription
PROCEDUREBlood collectionPeripheral blood will be collected via routine venipuncture procedure

Timeline

Start date
2021-09-17
Primary completion
2025-12-01
Completion
2025-12-01
First posted
2021-07-20
Last updated
2025-11-04

Locations

31 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT04968548. Inclusion in this directory is not an endorsement.