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Trial Title:
Screening for Early Lung Cancer in Shanghai, China
NCT ID:
NCT02185495
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Observer nodule detection
Description:
Radiologists will detect the nodules.
Arm group label:
High-risk individuals
Intervention type:
Device
Intervention name:
Computer-aided nodule detection
Description:
Computed-aided detection (CAD) software will be used to detect the nodules.
Arm group label:
High-risk individuals
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
35 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Changzheng Hospital
Address:
City:
Shanghai
Zip:
200003
Country:
China
Status:
Recruiting
Contact:
Last name:
Shiyuan Liu, Prof.MD.PhD.
Phone:
+86-13761304518
Email:
cjr.liushiyuan@vip.163.com
Investigator:
Last name:
ShiYuan Liu, Prof.MD.PhD.
Email:
Principal Investigator
Investigator:
Last name:
Ying Zhou, MD.
Email:
Sub-Investigator
Start date:
July 2014
Completion date:
September 2017
Lead sponsor:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Public Health Clinical Center
Agency class:
Other
Source:
Shanghai Changzheng Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02185495
