National Lung Screening Trial (NLST) Screening

Study Overview
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Brief Summary
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RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT) screening is more effective than chest radiography (CXR) screening in reducing death from lung cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR in screening individuals who are at high risk for developing lung cancer.

Detailed Description
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OBJECTIVES: Compare whether screening with low-dose helical CT scan vs chest x-ray reduces lung cancer-specific mortality in participants who are at high risk for developing lung cancer. OUTLINE: NLST participants were randomized to either low-dose helical CT or chest x-ray in equal proportions. A total of 53,454 participants were enrolled (26,722 in low-dose CT and 26,732 in chest radiography) at 33 screening centers across the United States. Screening was offered three times (at baseline and two annual follow-up examinations). The primary endpoint of the study was lung cancer mortality. The study arms were compared with regard to overall mortality, lung cancer incidence, and screening-related complications. All low-dose scanners and chest x-ray machines were certified for use and met NLST protocol requirements and American College of Radiology guidelines. Low-dose CT acquisitions and chest radiographs were interpreted by trained radiologists. Participants and their health care provider were informed of study examination results. Participants with abnormalities suspicious for lung cancer were contacted for information regarding diagnostic evaluation. Medical records were collected on diagnostic evaluation, medical complications, and initial treatment. Participants were then contacted at least annually by mail or telephone. The National Lung Screening Trial (NLST) represents the union of two NCI-sponsored efforts, the NCI Lung Screening Study and the American College of Radiology Imaging Network (ACRIN).

Official Title
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National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: low-dose helical computed tomography
* Device: chest radiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 55-74 years (pack-years = packs per day * years smoked) 30 or more pack-years of cigarette smoking history Former smokers: quit smoking within the previous 15 years Ability to lie on the back with arms raised over the head Signed informed consent form Exclusion Criteria: Metallic implants or devices in the chest or back, such as pacemakers or Harrington fixation rods Treatment for, or evidence of, any cancer other than nonmelanoma skin cancer or carcinoma in situ (with the exception of transitional cell carcinoma in situ or bladder carcinoma in situ) in the 5 years prior to eligibility assessment History of lung cancer History of removal of any portion of the lung, excluding needle biopsy Requirement for home oxygen supplementation Participation in another cancer screening trial Participation in a cancer prevention study, other than a smoking cessation study Unexplained weight loss of more than 15 pounds in the 12 months prior to eligibility assessment Recent hemoptysis Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment Chest CT examination in the 18 months prior to eligibility assessment

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Dose CT<br> | Device: low-dose helical computed tomography<br>* A LDCT is a computerized tomography image with low-dose technique without contrast. The scan is done from the neck to the diaphragm in one breath-hold.<br>* Other names: LDCT;|
| Experimental: Chest X-ray<br> | Device: chest radiography<br>* The chest x-ray in this study was a single posterior-anterior film done with the participant upright.<br>* Other names: CXR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Cancer Deaths | Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate. | All events through December 31, 2009; median follow-up 6.5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deaths From All Causes in All Randomized Participants. | Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants. | All events through December 31, 2009; median follow-up 6.5 years. | 
| Lung Cancer Diagnoses | Lung cancer diagnoses confirmed by medical record abstraction. | All events through December 31, 2009; median follow-up 6.5 years | 
| Complications of Diagnostic Evaluation Following a Positive Screening Test. | Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer. | One year from screening examination | 
| T0 (Baseline) Screening Results | Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0. | T0 (at study entry) | 
| T1 Screening Results | Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen. | T1 (one year after entry) | 
| T2 Screening Results | Results of radiologist's interpretation of images from LDCT or CXR screening exam at T2. Includes a comparison with images from T0 and T1 screens. | T2 (two years after entry) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small cell lung cancer, non-small cell lung cancer