National Lung Screening Trial
Brigham and Women’s Hospital
(617) 732-NLST
1-800-204-4595
NLST@partners.org
Study Design
This project describes a multicenter, randomized controlled trial of 10,000 individuals at high risk of lung cancer to address whether screening using lung cancer associated molecular markers in blood or sputum epithelial cells and low dose helical CT can improve lung cancer specific mortality. These screening tests have been shown to improve the detection of early lung cancers and lung carcinogenesis (premalignancy). High risk will be defined as age 55 years or greater with heavy smoking history. Following randomization, initial risk profiles will be obtained on both experimental and controls subjects using a standardized respiratory health and sociodemographic questionnaire as well as baseline spirometry. At some study sites sputum and blood samples will be collected from both experimental and control subjects and archived for future biomolecular analyses. In the experimental cohort, analysis for biomolecular markers will be performed at study entry. The experimental group will undergo annual screening with blood and sputum analyses for various biomolecular markers, sputum cytology, and low dose helical CT. Both groups will also complete annual respiratory health and quality of life questionnaires. The primary end point of the study is lung cancer specific mortality; intermediate end points of surgical stage and tumor size at time of diagnosis will be also assessed, as both are known to correlate with improved survival. The relative diagnostic accuracies of the imaging and molecular screening tests in distinguishing benign and malignant lung nodules will be compared using pathology (or accepted clinical surveillance) as the truth standard. The frequency of unnecessary thoracotomy for benign disease will be measured. Quality of life and cost effectiveness data will be used to examine the benefits of screening in defined high risk individuals.
Prior to randomization, standardized eligibility, health, sociodemographic, and quality of life questionnaires as well as spirometry will be performed. All participants will provide blood, sputum and urine samples for archive at study entry and at the time of the second incidence screen. Study participants will be randomized into an Experimental and a Control group. The Experimental group will undergo screening with low dose helical CT. The Control group will undergo screening with chest radiographs. Both groups will be screened annually for at least two incidence screens. Both groups will be contacted at six-month intervals to document interval health status and annually to complete quality of life questionnaires. Subgroups of both cohorts will complete questionnaires to determine the differential psychological impact of screening for lung cancer. Similarly, subgroups of Experimental and Control participants who have positive screening results will complete questionnaires to determine the psychological impact of positive screening tests, using as case-matched controls subgroups of Control and Experimental participants with negative screening CT results. This protocol is conducted in close coordination with the Lung Screening Study of NCI. The two studies comprise the National Lung Screening Trial (NLST).
BWH Lung Screening Trial
617-732-NLST
NLST@PARTNERS.ORG
Send Feedback to: 
