High Risk of Developing Lung Cancer
Conditions
Keywords
Lung cancer screening, Smokers or former smokers, Family history of lung cancer
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.
Interventions
RADIATIONCT scan & Early CDT Lung test
Sponsors
National Jewish Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Economics | One Year | Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination. |
Countries
United States
Outcome results
None listed