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


Phase 2
50 Years
75 Years
Open (Enrolling)
Both
High Risk of Developing Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Jim Jett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Jewish Health

Authority:

United States: Institutional Review Board

Study ID:

Oncimmune-2550

NCT ID:

NCT01700257

Start Date:

May 2012

Completion Date:

May 2016

Related Keywords:

  • High Risk of Developing Lung Cancer
  • Lung cancer screening
  • Smokers or former smokers
  • Family history of lung cancer
  • Lung Neoplasms

Name

Location
National Jewish Health Denver, Colorado  80206