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Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low dose computed tomography
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring Low dose CT screening, Family history of lung cancer

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. relatives of the lung cancer patients;
  2. age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old;
  3. compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation.

Exclusion Criteria:

  1. proved lung cancer either with or without treatment,
  2. presence of hemoptysis or history of remarkable lung fibrosis,
  3. any other cancer history or
  4. chest CT examination within one year

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Low dose computed tomography

    Arm Description

    All the Low dose computed tomography of lung was performed with 64 slices multidetectors CT in single hold breath covering entire lung. The protocol of scanning parameters (120KVp, 40-80 mA, 1.25 mm or less in thickness) was standardized. The raw data would be reconstructed to axial images (3 mm thickness and interval) and coronal images (3 mm thickness and interval). The scan should be finished in a single breath (15-20 second) from the thoracic inlet to adrenal glands.

    Outcomes

    Primary Outcome Measures

    Number of participants with lung cancer detected by low dose computed tomography

    Secondary Outcome Measures

    Detection rate of early lung cancer

    Full Information

    First Posted
    July 31, 2015
    Last Updated
    August 6, 2015
    Sponsor
    Taichung Veterans General Hospital
    Collaborators
    Ministry of Health and Welfare, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02519972
    Brief Title
    Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer
    Official Title
    Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taichung Veterans General Hospital
    Collaborators
    Ministry of Health and Welfare, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung cancer. Relatives with family history of lung cancer are at increased risk of lung cancer compared to those without a family history in pooled analysis. A prospective trial using LDCT of lung to screen the relatives with family history of lung cancer is needed.
    Detailed Description
    Investigators invited participants with family history to join in this study under the criteria of (1) relatives of the lung cancer patients; (2) age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old; (3) compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation. The participants with (1) proved lung cancer either with or without treatment, (2) presence of hemoptysis or history of remarkable lung fibrosis, (3) any other cancer history or (4) chest CT examination within one year would be excluded from the study. The study was planned to enroll 1000 participants from simplex families and 500 participants from multiplex families for lung LDCT screening. Multiplex family was defined as two or more family members with lung cancers, and simplex family as one family member with lung cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    Low dose CT screening, Family history of lung cancer

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low dose computed tomography
    Arm Type
    Experimental
    Arm Description
    All the Low dose computed tomography of lung was performed with 64 slices multidetectors CT in single hold breath covering entire lung. The protocol of scanning parameters (120KVp, 40-80 mA, 1.25 mm or less in thickness) was standardized. The raw data would be reconstructed to axial images (3 mm thickness and interval) and coronal images (3 mm thickness and interval). The scan should be finished in a single breath (15-20 second) from the thoracic inlet to adrenal glands.
    Intervention Type
    Device
    Intervention Name(s)
    low dose computed tomography
    Intervention Description
    Participants will receive 3 round of low dose computed tomography screening every year
    Primary Outcome Measure Information:
    Title
    Number of participants with lung cancer detected by low dose computed tomography
    Time Frame
    three years
    Secondary Outcome Measure Information:
    Title
    Detection rate of early lung cancer
    Time Frame
    three years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: relatives of the lung cancer patients; age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old; compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation. Exclusion Criteria: proved lung cancer either with or without treatment, presence of hemoptysis or history of remarkable lung fibrosis, any other cancer history or chest CT examination within one year
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gee-Chen Chang, MD, PhD
    Organizational Affiliation
    Taichung Veterans General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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