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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Jewish Health
Sponsor:
Information provided by (Responsible Party):
National Jewish Health
ClinicalTrials.gov Identifier:
NCT01700257
First received: October 2, 2012
Last updated: January 28, 2014
Last verified: January 2014

October 2, 2012
January 28, 2014
May 2012
May 2016   (final data collection date for primary outcome measure)
CT alone vs. both Early CDT-Lung test and CT scan. [ Time Frame: One year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01700257 on ClinicalTrials.gov Archive Site
Value of Early CDT-lung test in detecting cancer [ Time Frame: One year ] [ Designated as safety issue: No ]
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.
Same as current
Health Economics [ Time Frame: One Year ] [ Designated as safety issue: No ]
Comparison of the health economic costs of Early CDT-Lung test and CT scan when each is used individually or in combination.
Same as current
 
Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
High Risk of Developing Lung Cancer
  • Radiation: CT scan & Early CDT Lung test
    Other Names:
    • Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test)
    • for lung cancer screening purposes
  • Other: CT scan & Early CDT Lung test
    Other Name: CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.
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.
Interventions:
  • Radiation: CT scan & Early CDT Lung test
  • Other: CT scan & Early CDT Lung test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
May 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
No
Contact: Nina Thompson, BS 303-270-2564 thompsonn@njhealth.org
Contact: Melanie Phillips, BS 303-398-1921 phillipsm@njhealth.org
United States
 
NCT01700257
Oncimmune-2550
Yes
National Jewish Health
National Jewish Health
Not Provided
Principal Investigator: Jim Jett, MD National Jewish Health
National Jewish Health
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP