Screening for Early Lung Cancer in Shanghai, China

Phase 2

• Conditions: Lung Cancer
• Interventions: Behavioral: Observer nodule detection; Device: Computer-aided nodule detection

• Registration Number: NCT02185495
• Lead Sponsor: Shanghai Changzheng Hospital

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-05
• Study First Submitted QC: 2014-07-05
• Study First Posted: 2014-07-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-18
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-risk individuals	Observer nodule detection	The elder and heavy smokers, which are high-risk individuals for early lung cancer. These subjects will be examined using "Observer nodule detection" and " Computer-aided nodule detection".
High-risk individuals	Computer-aided nodule detection	The elder and heavy smokers, which are high-risk individuals for early lung cancer. These subjects will be examined using "Observer nodule detection" and " Computer-aided nodule detection".

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China