Chest Imaging, Breath, and Biomarkers in a Screening Trial

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01663155

Collaborator

(none)

1,424

Enrollment

Location

67.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	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 Design

Study Type:

Observational

Actual Enrollment :

1424 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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