Chest Imaging, Breath, and Biomarkers in a Screening Trial

NeuroTherapia, Inc.

Status: Completed

Conditions: Lung Cancer

Treatments: Device: chest x-ray with or without CAD, lose dose CT scan

Study type: Observational

Funder types: Other

Identifiers

NCT01663155

06-055 (Other Grant/Funding Number)

State of Ohio grant (Other Grant/Funding Number)

07-455

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,424 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,424 participants in 1 patient group

all enrolled subjects

Description:

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.

Treatment:

Device: chest x-ray with or without CAD, lose dose CT scan