Clinical trial · Observational
Chest Imaging, Breath, and Biomarkers in a Screening Trial
A Clinical Trial to Develop Chest Imaging, Breath, and Biomarkers in a Screening Trial
NCT01663155CI-TRIAL-00027673completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chest x-ray with or without CAD, lose dose CT scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Device: chest x-ray with or without CAD, lose dose CT scan
Primary outcomes (1)
- measure
- The sensitivities of chest x-ray with CAD and chest CT
- timeFrame
- One year after scan
- 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.
Secondary outcomes (5)
- measure
- Disease-specific mortality between screening with chest x-ray and CAD versus no screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDMazzone PJ, Obuchowski N, Fu AZ, Phillips M, Meziane M. Quality of life and healthcare use in a randomized controlled lung cancer screening study. Ann Am Thorac Soc. 2013 Aug;10(4):324-9. doi: 10.1513/AnnalsATS.201301-007OC. PMID 23952850
- DERIVEDMazzone PJ, Obuchowski N, Phillips M, Risius B, Bazerbashi B, Meziane M. Lung cancer screening with computer aided detection chest radiography: design and results of a randomized, controlled trial. PLoS One. 2013;8(3):e59650. doi: 10.1371/journal.pone.0059650. Epub 2013 Mar 20. PMID 23527241