Clinical trial NCT01663155: Chest Imaging, Breath, and Biomarkers in a Screening Trial
Official title: A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: lung cancer
chest x-ray
CT scan
computer aided detection (CAD)
screening
smokers
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 1424
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: The sensitivities of chest x-ray with CAD and chest CT
timeFrame: One year after scan
Secondary outcomes:
measure: Disease-specific mortality between screening with chest x-ray and CAD versus no screening
timeFrame: One year after scan
measure: All-cause mortality rate between screening with chest x-ray and CAD versus no screening
timeFrame: One year after scan
measure: Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls
timeFrame: One year after scan
measure: 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
timeFrame: One year after scan
measure: The quality of life between screening with chest x-ray and CAD versus no screening.
timeFrame: One year after scan
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Micheal Phillips, M.D.
role: STUDY_CHAIR
affiliation: Chair of Thoracic Imaging
name: Moulay Meziane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazzone PJ, Obuchowski N, Fu AZ, Phillips M, Meziane M. Quality of life and healthcare use in a randomized controlled lung cancer screening study. Ann Am Thorac Soc. 2013 Aug;10(4):324-9. doi: 10.1513/AnnalsATS.201301-007OC.
citation: Mazzone PJ, Obuchowski N, Phillips M, Risius B, Bazerbashi B, Meziane M. Lung cancer screening with computer aided detection chest radiography: design and results of a randomized, controlled trial. PLoS One. 2013;8(3):e59650. doi: 10.1371/journal.pone.0059650. Epub 2013 Mar 20.