Skip to main content
OpenTrials
Completed

NCT Number: NCT01700257

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

High Risk of Developing Lung Cancer Behavior Health Behavior Smoking Cessation

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT scan & Early CDT Lung test

Radiation

Other names: Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test), for lung cancer screening purposes

CT scan & Early CDT Lung test

Other

Other names: CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.

Primary outcomes

  1. CT alone vs. both Early CDT-Lung test and CT scan.

    Time frame: 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 outcomes

  1. Value of Early CDT-lung test in detecting cancer

    Time frame: 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 outcomes

  1. Health Economics

    Time frame: One Year

    Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2012
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.