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Trial Title:
Screening for Lung Cancer in Subjects With Family History of Lung Cancer
NCT ID:
NCT05762731
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung cancer
Screening
Family history
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Low dose CT thorax
Description:
A multi-detector row CT scanner with minimum section collimation of ≤1 mm and minimum
number of data acquisition channels ≥ 16will be employed.
Arm group label:
First degree relatives of lung cancer patients
Intervention type:
Diagnostic Test
Intervention name:
Low dose CT thorax
Description:
Control subjects will also proceed to CT thorax, and outcome measures be compared to
subjects
Arm group label:
Control group
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.
Criteria for eligibility:
Study pop:
Subjects with lung cancer and to invite them to participate by (i) naming their first
degree relatives to be further invited for the following study procedures, and (ii)
provide a blood and urine sample as detailed below for archival and future analysis of
relevant biomarkers. The patients' first degree relatives will be contacted by PA's
research team and invited for study participation with the following study procedures.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
50 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
University of Hong Kong
Address:
City:
Hong Kong
Zip:
0
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
David CL Lam, MBBS, FRCP(Edin), FCCP, FACP
Phone:
+852 2255 5814
Email:
dcllam@hku.hk
Start date:
February 1, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
The Queen Elizabeth Hospital
Agency class:
Other
Collaborator:
Agency:
Kwong Wah Hospital
Agency class:
Other
Collaborator:
Agency:
Hong Kong Sanatorium & Hospital
Agency class:
Industry
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05762731
http://www3.ha.org.hk/cancereg/
