Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

September 8, 2016 updated by: Baohui Han, Shanghai Chest Hospital

Community-based Early Stage Lung Cancer Screening With Low-dose Computed Tomography in China

The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Baohui Han, MD, PhD
  • Phone Number: 3301 86-21-62821990
  • Email: xkyyhan@gmail.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible participants were those aged 45-70 years, and with either of the following risk factors:

    1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
    2. malignant tumors history in immediate family members;
    3. personal cancer history;
    4. professional exposure to carcinogens;
    5. long term exposure to second-hand smoke;
    6. long term exposure to cooking oil fumes.

Exclusion Criteria:

  1. Had a CT scan of chest within last 12 months
  2. History of any cancer within 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Screening Arm
LDCT was performed at baseline + 2 biennial repeated LDCT rounds
Device: Low Dose Computed Tomography
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.
No Intervention: Passive Arm
Eligible subjects were randomized to follow up in usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung cancer incidence rate
Time Frame: 5 years
Assess the number of lung cancer incidences after each round of screening in both arms. Compared the stage differences between screening arm and usual care arm.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung cancer mortality
Time Frame: 5 years
Assess lung cancer mortality in both arms within next 5 years after first round of screening.
5 years
All-cause mortality
Time Frame: 5 years
Assess all-cause mortality in both arms within next 5 years after first round of screening.
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nodule detection rate
Time Frame: One year
Assess nodule detection rate, and the types and sizes of nodules detected in LDCT screening arm.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Investigators

  • Principal Investigator: Baohui Han, MD, PhD, Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013ZYJB0402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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