Chest Imaging, Breath, and Biomarkers in a Screening Trial

A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: chest x-ray with or without CAD, lose dose CT scan

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.

• Study Type: Observational
• Enrollment (Actual): 1424

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivities of chest x-ray with CAD and chest CT	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.	One year after scan

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific mortality between screening with chest x-ray and CAD versus no screening	Mortality rate in screening x-ray vs CAD	One year after scan
All-cause mortality rate between screening with chest x-ray and CAD versus no screening	All cause mortality rate	One year after scan
Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls	Time between randomization and symptom	One year after scan
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	Cancer detection rate between chest x-ray and CAD	One year after scan
The quality of life between screening with chest x-ray and CAD versus no screening.	Quality of life between the chest x-ray group and the CAD group	One year after scan

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Study Chair: Micheal Phillips, M.D., The Cleveland Clinic; Principal Investigator: Moulay Meziane, MD, Chair of Thoracic Imaging

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 10, 2008
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 13, 2012

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: lung cancer; screening; smokers; chest x-ray; CT scan; computer aided detection (CAD)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• 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)