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Chest Imaging, Breath, and Biomarkers in a Screening Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663155
First Posted: August 13, 2012
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Moulay Meziane, MD, The Cleveland Clinic
  Purpose
The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.

Condition Intervention
Lung Cancer Device: chest x-ray with or without CAD, lose dose CT scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial

Resource links provided by NLM:


Further study details as provided by Moulay Meziane, MD, The Cleveland Clinic:

Primary Outcome Measures:
  • The sensitivities of chest x-ray with CAD and chest CT [ Time Frame: One year after scan ]
    The false positive rates of chest x-ray with CAD and chest CT will be compared. The analysis will be based on the study subjects from this prospective study who test positive with chest x-ray and/or CT and who are determined not to have lung cancer during the follow-up period.


Secondary Outcome Measures:
  • Disease-specific mortality between screening with chest x-ray and CAD versus no screening [ Time Frame: One year after scan ]
    Mortality rate in screening x-ray vs CAD

  • All-cause mortality rate between screening with chest x-ray and CAD versus no screening [ Time Frame: One year after scan ]
    All cause mortality rate

  • Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls [ Time Frame: One year after scan ]
    Time between randomization and symptom

  • Does lung cancer screening with chest x-rays and computer aided detection (CAD) reduce the incidence of symptomatic advanced lung cancer in a high risk population [ Time Frame: One year after scan ]
    Cancer detection rate between chest x-ray and CAD

  • The quality of life between screening with chest x-ray and CAD versus no screening. [ Time Frame: One year after scan ]
    Quality of life between the chest x-ray group and the CAD group


Biospecimen Retention:   Samples With DNA
Blood draw includes 2 10 mL red top tubes for serum retrieval, and 2 7 mL EDTA tubes for plasma and buffy coat retrieval

Enrollment: 1424
Study Start Date: September 2008
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
all enrolled subjects
Intervention is chest x-ray and CT scan. The chest x-ray image is read first without computer aided detection (CAD) and then a second time with computer aided detection (CAD) the CT scan is read by one reader. Subjects are asked to contribute breath and blood samples.
Device: chest x-ray with or without CAD, lose dose CT scan
PA view, low dose CT scan
Other Names:
  • CAD
  • computer aided detection

Detailed Description:
The fight against lung cancer is waged on three major fronts: prevention, detection and treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT scan can detect disease earlier when treatment is more effective. If we improve the detection of disease, we will see if screening reduces the incidence of symptomatic advanced lung cancer relative to no screening in people at high risk to develop lung cancer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary care physicians or any other physician may refer potential candidates. Additionally, subjects may see marketing materials and contact the research team directly. There is no restriction to the area of residence of subjects.
Criteria

Inclusion Criteria:

  • ages 40-75 years
  • If ages 40-59, then one of the following criteria needs to be met:

    • Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR
    • current or ex-smoker with > 25 pack years and COPD OR
    • current or ex-smoker with a > 35 pack year history
  • If ages 60-75, then one of the following additional criteria needs to be met:

    • Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR
    • Current or ex-smoker with >25 pack years and COPD OR
    • Current or ex-smoker with a >30 pack year history
  • Subject is able to return to Cleveland Clinic for annual follow-up screening
  • Subject is willing to sign a medical release form

Exclusion Criteria:

  • Current health requires oxygen
  • Have had a chest x-ray or CT of the chest within the last 6 months
  • Previous pneumonectomy
  • Lobectomy of the lung within the last 5 years
  • Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer
  • A medical condition that would prevent treatment for lung cancer
  • Within the last 6 weeks, one of the following has occured:

    • A new cough or chronic cough that has gotten worse
    • Either new shortness of breath, or any worsening of shortness of breath
    • A cough producing blood
    • Constant chest pain
    • Respiratory infection, pneumonia, or cold
    • Unintentional and unexplained weight loss greater than 5% of total body weight
  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): NCT01663155


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Micheal Phillips, M.D. The Cleveland Clinic
Principal Investigator: Moulay Meziane, MD Chair of Thoracic Imaging
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Moulay Meziane, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01663155     History of Changes
Other Study ID Numbers: 07-455
State of Ohio grant ( Other Grant/Funding Number: 06-055 )
06-055 ( Other Grant/Funding Number: State of Ohio )
First Submitted: November 10, 2008
First Posted: August 13, 2012
Last Update Posted: May 18, 2017
Last Verified: May 2017

Keywords provided by Moulay Meziane, MD, The Cleveland Clinic:
lung cancer
chest x-ray
CT scan
computer aided detection (CAD)
screening
smokers