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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
  Purpose

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.


Condition Intervention Phase
High Risk of Developing Lung Cancer
Radiation: CT scan & Early CDT Lung test
Other: CT scan & Early CDT Lung test
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 1600
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700257

Contacts
Contact: Nina Thompson, BS 303-270-2564 thompsonn@njhealth.org
Contact: Melanie Phillips, BS 303-398-1921 phillipsm@njhealth.org

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Nina Thompson, BS    303-270-2564    thompsonn@njhealth.org   
Contact: Melanie Phillips, BS    303-398-1921    phillipsm@njhealth.org   
Principal Investigator: Jim Jett, MD         
Sponsors and Collaborators
National Jewish Health
Investigators
Principal Investigator: Jim Jett, MD National Jewish Health
  More Information

No publications provided

Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT01700257     History of Changes
Other Study ID Numbers: Oncimmune-2550
Study First Received: October 2, 2012
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
Lung cancer screening
Smokers or former smokers
Family history of lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014