Screening for Early Lung Cancer in Shanghai, China

Lung Cancer Clinical Trial

Official title:

Screening and Diagnosing for Early Lung Cancer in Shanghai Communities With Imaging Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02185495
• Other study ID #: 13411950100
• Status: Recruiting
• Phase: Phase 2
• First received: July 5, 2014
• Last updated: December 16, 2014
• Start date: July 2014
• Est. completion date: September 2017

Study information

• Verified date: November 2014
• Source: Shanghai Changzheng Hospital
• Contact: Shiyuan Liu, MD
• Phone: +86-13761304518
• Email: cjr.liushiyuan[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 74 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Observer nodule detection
Radiologists will detect the nodules.

Device:
• Computer-aided nodule detection
Computed-aided detection (CAD) software will be used to detect the nodules.

Locations

Country	Name	City	State
China	Changzheng Hospital	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	Fudan University, Ruijin Hospital, Shanghai Public Health Clinical Center, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer	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.	24months	No
Secondary	The false positive rates between low-dose computed tomography and low-dose computed tomography with computer aided detection will be compared		24months	No
Secondary	Nodule detection rate		6 months	No