Screening for Early Lung Cancer in Shanghai, China

NCT ID: NCT02185495

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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".

Group Type EXPERIMENTAL

Observer nodule detection

Intervention Type BEHAVIORAL

Radiologists will detect the nodules.

Computer-aided nodule detection

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observer nodule detection

Radiologists will detect the nodules.

Intervention Type BEHAVIORAL

Computer-aided nodule detection

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Liu ShiYuan

Shanghai Changzheng Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shiyuan Liu, MD

Role: STUDY_DIRECTOR

Radiology Department of Shanghai Changzheng Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shiyuan Liu, MD

Role: CONTACT

Phone: +86-13761304518

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shiyuan Liu, Prof.MD.PhD.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13411950100

Identifier Type: -

Identifier Source: org_study_id