Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker

Not Applicable

Completed

• Conditions: High Risk of Developing Lung Cancer
• Interventions: Other: CT scan & Early CDT Lung test

• Registration Number: NCT01700257
• Lead Sponsor: National Jewish Health

Brief Summary

Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.

Detailed Description

In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Status Verified: 2020-12
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1361

Inclusion Criteria

• Smokers or former smokers
• At least 20 pack year history of smoking
• Ages 50 - 75

Exclusion Criteria

• Had a CT scan of chest within last 24 months
• History of any cancer within 10 yrs (except skin cancer or cervical cancer)
• A serious illness that decreases life expectancy to less than 5 years
• Any current use of Oxygen
• Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion
• Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT scan & Early CDT Lung test	CT scan & Early CDT Lung test	Every study participant receives a CT scan \& Early CDT-Lung test (biomarker blood test) for lung cancer screening purposes.

Primary Outcome Measures

Name	Time	Method
CT alone vs. both Early CDT-Lung test and CT scan.	One year	Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.

Secondary Outcome Measures

Name	Time	Method
Value of Early CDT-lung test in detecting cancer	One year	Assess the value of Early CDT-lung test in detecting lung cancer in individuals who are CT scan negative but positive for Early CDT-lung.

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States