Lung Cancer
Conditions
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.
Interventions
BEHAVIORALObserver nodule detection
Radiologists will detect the nodules.
DEVICEComputer-aided nodule detection
Computed-aided detection (CAD) software will be used to detect the nodules.
Sponsors
Shanghai Zhongshan Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Fudan University
Ruijin Hospital
Shanghai Public Health Clinical Center
Shanghai Changzheng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 74 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactShiyuan Liu, MD
Outcome results
None listed