National Lung Screening Trial A Randomized Trial Comparing Low-dose Helical CT With Chest Xray for Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53,454
- 试验地点
- 66
- 主要终点
- Lung Cancer Deaths
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Lung Cancer Deaths
时间窗: All events through December 31, 2009; median follow-up 6.5 years.
Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.
次要结局
- Deaths From All Causes in All Randomized Participants.(All events through December 31, 2009; median follow-up 6.5 years.)
- Lung Cancer Diagnoses(All events through December 31, 2009; median follow-up 6.5 years)
- Complications of Diagnostic Evaluation Following a Positive Screening Test.(One year from screening examination)
- T0 (Baseline) Screening Results(T0 (at study entry))
- T1 Screening Results(T1 (one year after entry))
- T2 Screening Results(T2 (two years after entry))