Clinical trial NCT02519972: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Low dose CT screening
Family history of lung cancer
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2015-08-11
Enrollment: 1102
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with lung cancer detected by low dose computed tomography
timeFrame: three years
Secondary outcomes:
measure: Detection rate of early lung cancer
timeFrame: three years
Other outcomes:
Locations:
Study officials:
affiliation: Taichung Veterans General Hospital
name: Gee-Chen Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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