Chest Imaging, Breath, and Biomarkers in a Screening Trial

Completed

• Conditions: Lung Cancer
• Interventions: Device: chest x-ray with or without CAD, lose dose CT scan

• Registration Number: NCT01663155
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-13
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1424

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all enrolled subjects	chest x-ray with or without CAD, lose dose CT scan	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.

Primary Outcome Measures

Name	Time	Method
The sensitivities of chest x-ray with CAD and chest CT	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

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States