Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
High Risk of Developing Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Lung cancer screening, Smokers or former smokers, Family history of lung cancer
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Name: CT scan & Early CDT Lung test Type: Radiation
Name: CT scan & Early CDT Lung test Type: Other
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 50 Years
Gender: Both
Criteria: 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
National Jewish Health
Denver, Colorado, United States
Status: Recruiting
Contact: Melanie Phillips, BS - 303-398-1921 -
Start Date
May 2012
Completion Date
May 2016
National Jewish Health
National Jewish Health
Record processing date processed this data on July 28, 2015 page