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Screening for Early Lung Cancer in Shanghai, China

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Observer nodule detection

Computer-aided nodule detection

About this trial

This is an interventional screening trial for Lung Cancer

Eligibility Criteria

35 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-risk individuals

Arm Description

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".

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The false positive rates between low-dose computed tomography and low-dose computed tomography with computer aided detection will be compared

Nodule detection rate

Full Information

NCT ID

NCT02185495

First Posted

July 5, 2014

Last Updated

December 16, 2014

Sponsor

Shanghai Changzheng Hospital

Collaborators

Shanghai Zhongshan Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Fudan University, Ruijin Hospital, Shanghai Public Health Clinical Center

1. Study Identification

Unique Protocol Identification Number

NCT02185495

Brief Title

Screening for Early Lung Cancer in Shanghai, China

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Changzheng Hospital

Collaborators

Shanghai Zhongshan Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Fudan University, Ruijin Hospital, Shanghai Public Health Clinical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High-risk individuals

Arm Type

Experimental

Arm Description

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".

Intervention Type

Behavioral

Intervention Name(s)

Observer nodule detection

Intervention Description

Radiologists will detect the nodules.

Intervention Type

Device

Intervention Name(s)

Computer-aided nodule detection

Intervention Description

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

Primary Outcome Measure Information:

Title

The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer

Description

Time Frame

24months

Secondary Outcome Measure Information:

Title

The false positive rates between low-dose computed tomography and low-dose computed tomography with computer aided detection will be compared

Time Frame

24months

Title

Nodule detection rate

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shiyuan Liu, MD

Phone

+86-13761304518

cjr.liushiyuan@vip.163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shiyuan Liu, MD

Organizational Affiliation

Radiology Department of Shanghai Changzheng Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Changzheng Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shiyuan Liu, Prof.MD.PhD.

Phone

+86-13761304518

cjr.liushiyuan@vip.163.com

First Name & Middle Initial & Last Name & Degree

ShiYuan Liu, Prof.MD.PhD.

First Name & Middle Initial & Last Name & Degree

Ying Zhou, MD.

12. IPD Sharing Statement

Learn more about this trial

Screening for Early Lung Cancer in Shanghai, China

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