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Chest Imaging, Breath, and Biomarkers in a Screening Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Moulay Meziane, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01663155
First received: November 10, 2008
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • The sensitivities of chest x-ray with CAD and chest CT [ Time Frame: March, 2012 for scanning results only ] [ Designated as safety issue: No ]
    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: March, 2013 continued through follow up ] [ Designated as safety issue: No ]
  • All-cause mortality rate between screening with chest x-ray and CAD versus no screening [ Time Frame: March, 2013 ] [ Designated as safety issue: No ]
  • Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls [ Time Frame: March, 2013 through follow up ] [ Designated as safety issue: No ]
  • 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: March, 2013 ] [ Designated as safety issue: No ]
  • The quality of life between screening with chest x-ray and CAD versus no screening. [ Time Frame: March, 2013 ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 1000
Study Start Date: September 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by The Cleveland Clinic

Additional 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, 06-055
Study First Received: November 10, 2008
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

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

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 May 23, 2013