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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: low dose computed tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose computed tomography<br>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. | Device: low dose computed tomography<br>* Participants will receive 3 round of low dose computed tomography screening every year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with lung cancer detected by low dose computed tomography |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of early lung cancer |  | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low dose CT screening, Family history of lung cancer