A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial
40 Years
75 Years
Both
Lung Cancer
Trial Information
A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The sensitivities of chest x-ray with CAD and chest CT
Outcome Description:
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.
Outcome Time Frame:
March, 2012 for scanning results only
Safety Issue:
No
Principal Investigator
Micheal Phillips, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Institutional Review Board
Study ID:
07-455
NCT ID:
NCT01663155
Start Date:
September 2008
Completion Date:
March 2013
Related Keywords:
- Lung Cancer
- lung cancer
- chest x-ray
- CT scan
- computer aided detection (CAD)
- screening
- smokers
- Lung Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic | Cleveland, Ohio 44195 |
