Screening for Lung Cancer in Subjects With Family History of Lung Cancer

Recruiting

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Low dose CT thorax

• Registration Number: NCT05762731
• Lead Sponsor: The University of Hong Kong

Brief Summary

Lung cancer can be detected via screening of high-risk individuals, i.e current or ex-heavy smokers, with low-dose computer tomography (LDCT) of thorax. The National Lung Screening Trial in US and the NELSON trial in Europe demonstrated reduction in lung cancer mortality with LDCT screening for lung cancer. In Hong Kong, however, there is a prominence of female never-smokers with lung cancer. There is no identifiable risk factors for non-smokers with lung cancer except family history of lung cancer. The hypothesis is that lung cancer screening for subjects with family history of lung cancer, can detect early lung cancer.

Detailed Description

The primary aim of this prospective study is to find out the rate of lung cancer detection in subjects who are first degree relatives of lung cancer patients. Secondary aims include studying the characteristics of screen-detected lung cancer. This is a multi-centered prospective cohort study. 1,520 subjects who are first degree relatives of lung cancer patients at four public hospitals in Hong Kong will be screened. Intervention Detailed questionnaires and LDCT Thorax will be performed. The primary outcome measure is the number of lung cancers detected by this study. The screening-detection rate of lung cancer in first-degree relatives of lung cancer patients will be estimated.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-02-01
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-10
• Last Update Posted: 2023-03-10
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1520

Inclusion Criteria

• Age 50-75, men or women, smokers or non-smokers
• Being first degree relatives (Siblings, children, and parents) of lung cancer subjects
• Having no known lung cancer before

Exclusion Criteria

• Non-Chinese
• Mentally incompetent to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Low dose CT thorax	Non-lung cancer subjects who are not related any lung cancer patients
First degree relatives of lung cancer patients	Low dose CT thorax	Age 50-75, men or women, smokers or non-smokers. Being first degree relatives (siblings, children and parents) of lung cancer subjects. Having no known lung cancer before.

Primary Outcome Measures

Name	Time	Method
The rate of lung cancer detection in subjects with family history of lung cancer	An average of 2.5 years	The number of screening-detected lung cancer among first degree relatives of lung cancer patients.

Secondary Outcome Measures

Name	Time	Method
The characteristics of screening detected lung cancer	An average of 2.5 years	Stage distribution of lung cancer detected.

Trial Locations

Locations (1)

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong