Screening for Early Lung Cancer in Shanghai, China

NCT02185495 | Unknown Phase 2 DMC

• 1 other identifier: 13411950100
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

High-risk individuals

EXPERIMENTAL

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; Device: Computer-aided nodule detection

Interventions

Observer nodule detection BEHAVIORAL

Radiologists will detect the nodules.

High-risk individuals

Computer-aided nodule detection DEVICE

Computed-aided detection (CAD) software will be used to detect the nodules.

High-risk individuals

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Fudan University: collaborator
• Ruijin Hospital: collaborator
• Shanghai Public Health Clinical Center: collaborator

Study Sites (1)

Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shiyuan Liu, MD

  Radiology Department of Shanghai Changzheng Hospital

  STUDY DIRECTOR

Central Study Contacts

Shiyuan Liu, MD

CONTACT

+86-13761304518; cjr.liushiyuan@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Changzheng Hospital

Study Record Dates

• First Submitted: July 5, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 18, 2014

Record last verified: 2014-11

Locations

CN (1)