Screening and Diagnosing for Early Lung Cancer in Shanghai Communities With Imaging Procedures
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Shanghai Changzheng Hospital
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer
Study Overview
Brief Summary
Imaging procedures including chest X-ray and low-dose computed tomography may be effective in lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined with computer aided detection （CAD) is more effective than LDCT in screening of early lung cancer.
Detailed Description
The randomized clinical trial is to investigate and compare the effectiveness of CAD-guided low-dose computed tomography and low-dose computed tomography in lung cancer screening for community individuals in Shanghai, China. Thus, an imaging protocol which can detect early lung cancer in asymptomatic high risk patients will be proposed.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age of 55 to 74 years; smoking history of at least 30 pack-years; and if former smoker, have quit within 15 years
- •Age 50 or older ,20 or more pack-year history of smoking, and one additional risk factor (occupational exposure, residential radon exposure, cancer history, family history of lung cancer, history of lung disease)
- •Age 35 and one additional risk factor
- •Ability to accept LDCT examination and sign informed consent form
Exclusion Criteria
- •Individuals with any symptoms suggestive of lung cancer （e.g., vigorous coughing, chest pain, weight loss, blood-stained sputum）
- •Individuals with acute pulmonary abnormalities or those in poor health conditions or those have metallic implants or devices in the chest or back will be excluded due to the potential impact on the results as well as difficulty of acquiring the images.
- •Pregnant women
Outcomes
Primary Outcomes
The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer
Time Frame: 24months
A questionaire will be recorded for each subject, including demographics, smoking history and disease history, etc. If a pulmonary nodule was found, the location, shape, size, margin and density will be recorded. A subject with a suspected malignant nodule, which was detected either by a radiologist or computed-aiding detection software, will refer to a physician for further management. Finally, the sensitivities of radiologist or software detection will be calculated.
Secondary Outcomes
- The false positive rates between low-dose computed tomography and low-dose computed tomography with computer aided detection will be compared(24months)
- Nodule detection rate(6 months)
Investigators
Liu ShiYuan
Shanghai Changzheng Hospital
Shanghai Changzheng Hospital