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Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low Dose Computed Tomography
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring lung cancer screening, low-dose CT, high-risk population

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Chest hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Screening Arm

Passive Arm

Arm Description

LDCT was performed at baseline + 2 biennial repeated LDCT rounds

Eligible subjects were randomized to follow up in usual care

Outcomes

Primary Outcome Measures

Lung cancer incidence rate
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.

Secondary Outcome Measures

Lung cancer mortality
Assess lung cancer mortality in both arms within next 5 years after first round of screening.
All-cause mortality
Assess all-cause mortality in both arms within next 5 years after first round of screening.

Full Information

First Posted
September 8, 2016
Last Updated
September 8, 2016
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02898441
Brief Title
Early Stage Lung Cancer Screening With Low-dose Computed Tomographic
Official Title
Community-based Early Stage Lung Cancer Screening With Low-dose Computed Tomography in China
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer screening, low-dose CT, high-risk population

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening Arm
Arm Type
Active Comparator
Arm Description
LDCT was performed at baseline + 2 biennial repeated LDCT rounds
Arm Title
Passive Arm
Arm Type
No Intervention
Arm Description
Eligible subjects were randomized to follow up in usual care
Intervention Type
Device
Intervention Name(s)
Low Dose Computed Tomography
Intervention Description
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.
Primary Outcome Measure Information:
Title
Lung cancer incidence rate
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Lung cancer mortality
Description
Assess lung cancer mortality in both arms within next 5 years after first round of screening.
Time Frame
5 years
Title
All-cause mortality
Description
Assess all-cause mortality in both arms within next 5 years after first round of screening.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Nodule detection rate
Description
Assess nodule detection rate, and the types and sizes of nodules detected in LDCT screening arm.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligible participants were those aged 45-70 years, and with either of the following risk factors: history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; malignant tumors history in immediate family members; personal cancer history; professional exposure to carcinogens; long term exposure to second-hand smoke; long term exposure to cooking oil fumes. Exclusion Criteria: Had a CT scan of chest within last 12 months History of any cancer within 5 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baohui Han, MD, PhD
Phone
86-21-62821990
Ext
3301
Email
xkyyhan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanwei Zhang, MD, PhD
Phone
86-21-62821990
Ext
3306
Email
zhangyw198691@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baohui Han, MD, PhD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han, MD,PhD
Phone
86-21-62821990
Ext
3301
Email
xkyyhan@gmail.com
First Name & Middle Initial & Last Name & Degree
Yanwei Zhang, MD,PhD
Phone
86-15216687683
Email
zhangyw198691@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

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