Lung EpiCheck Biomarkers Development Study

Recruiting

• Conditions: Lung Cancer
• Interventions: Other: Blood collection

• Registration Number: NCT06245876
• Lead Sponsor: Nucleix Ltd.

Brief Summary

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

Detailed Description

This is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.

Study Timeline

• Study Start: 2022-05-17
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Status Verified: 2024-02
• Study First Posted: 2024-02-07
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control Cohort	Blood collection	Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years.
USPSTF At Risk - Control Cohort	Blood collection	Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years.
Cases Cohort	Blood collection	Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects.

Primary Outcome Measures

Name	Time	Method
Performance	Day 1	Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value).

Trial Locations

Locations (10)

Ochsner LSU Health Shreveport - Regional Urology; 🇺🇸 Shreveport, Louisiana, United States

Comprehensive Urology; 🇺🇸 Southfield, Michigan, United States

Life Spring Clinical Research; 🇺🇸 Miami, Florida, United States

Carmel Medical Center; 🇮🇱 Haifa, Israel

Michigan Institute of Urology, P.C.; 🇺🇸 Troy, Michigan, United States

ZGT Medical Center; 🇳🇱 Hengelo, Netherlands

Emerald Coast OBGYN; 🇺🇸 Panama City, Florida, United States

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

National Koranyi Institute for Pulmonology; 🇭🇺 Budapest, Hungary

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States