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
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
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
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
NCT ID
NCT02519972
First Posted
July 31, 2015
Last Updated
August 6, 2015
Sponsor
Taichung Veterans General Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
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
Citations:
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Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer
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