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

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ClinicalTrials.gov Identifier: NCT01700257
Recruitment Status : Recruiting
First Posted : October 4, 2012
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer
Study Start Date : May 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700257


Contacts
Contact: Melanie Phillips, BS 303-398-1921 phillipsm@njhealth.org

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

Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT01700257     History of Changes
Other Study ID Numbers: Oncimmune-2550
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

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