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

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT04968548
• Lead Sponsor: Nucleix Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-20
• Study Start: 2021-09-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of blood samples	24 Months	Collect blood to support the development and validation of a multi analyte test for lung cancer screening
Clinical data collection	24 Months	Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening

Secondary Outcome Measures

Name	Time	Method
Specificity	36 Months	Performance of the assay in terms of Specificity
Negative Predictive Value	36 Months	Performance of the assay in terms of NPV (negative predictive value)
Performance	36 Months	Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value)
Positive Predictive Value	36 Months	Performance of the assay in terms of PPV (positive predictive value)
Sensitivity	36 Months	Performance of the assay in terms of Sensitivity

Trial Locations

Locations (31)

Scripps Memorial Hospital; 🇺🇸 Encinitas, California, United States

Centura Health; 🇺🇸 Lakewood, Colorado, United States

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States

Orlando Health, Inc.; 🇺🇸 Orlando, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

St. Elizabeth Edgewood Hospital; 🇺🇸 Edgewood, Kentucky, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Owensboro Health; 🇺🇸 Owensboro, Kentucky, United States

Johns Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States

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