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Completed

NCT Number: NCT01663155

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

PA view, low dose CT scan

Other names: CAD, computer aided detection

Primary outcomes

  1. The sensitivities of chest x-ray with CAD and chest CT

    Time frame: 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 outcomes

  1. Disease-specific mortality between screening with chest x-ray and CAD versus no screening

    Time frame: One year after scan

    Mortality rate in screening x-ray vs CAD

  2. All-cause mortality rate between screening with chest x-ray and CAD versus no screening

    Time frame: One year after scan

    All cause mortality rate

  3. Length of time between randomization and the incidence of symptomatic advanced lung cancer for screened subjects versus controls

    Time frame: One year after scan

    Time between randomization and symptom

  4. 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

    Time frame: One year after scan

    Cancer detection rate between chest x-ray and CAD

  5. The quality of life between screening with chest x-ray and CAD versus no screening.

    Time frame: One year after scan

    Quality of life between the chest x-ray group and the CAD group

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2012
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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