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

High Risk of Developing Lung Cancer Clinical Trial

Official title:

Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700257
• Other study ID #: Oncimmune-2550
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 7, 2020

Study information

• Verified date: December 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1361
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• High Risk of Developing Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• CT scan & Early CDT Lung test

Other:
• CT scan & Early CDT Lung test

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Economics	Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination.	One Year
Primary	CT alone vs. both Early CDT-Lung test and CT scan.	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.	One year
Secondary	Value of Early CDT-lung test in detecting cancer	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.	One year