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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: low dose computed tomography

• Registration Number: NCT02519972
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2015-07-31
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-06
• Last Update Submitted: 2015-08-06
• Study First Posted: 2015-08-11
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low dose computed tomography	low dose computed tomography	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with lung cancer detected by low dose computed tomography	three years

Secondary Outcome Measures

Name	Time	Method
Detection rate of early lung cancer	three years