Screening for Early Lung Cancer in Shanghai, China

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Observer nodule detection; Device: Computer-aided nodule detection

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 Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Recruiting
      • Changzheng hospital
      • Contact: Shiyuan Liu, Prof.MD.PhD.; Phone Number: +86-13761304518; Email: cjr.liushiyuan@vip.163.com
      • Principal Investigator: ShiYuan Liu, Prof.MD.PhD.
      • Sub-Investigator: Ying Zhou, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-risk individuals; 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".	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Collaborators: Fudan University; Shanghai Zhongshan Hospital; Ruijin Hospital; Shanghai Public Health Clinical Center; Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Study Director: Shiyuan Liu, MD, Radiology Department of Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: July 5, 2014
• First Submitted That Met QC Criteria: July 5, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 13411950100