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

March 6, 2023 updated by: The University of Hong Kong
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • University of Hong Kong
        • Contact:
          • David CL Lam, MBBS, FRCP(Edin), FCCP, FACP
          • Phone Number: +852 2255 5814
          • Email: dcllam@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First degree relatives of lung cancer patients
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.
Diagnostic test: Low dose CT thorax
A multi-detector row CT scanner with minimum section collimation of ≤1 mm and minimum number of data acquisition channels ≥ 16will be employed.
Diagnostic test: Low dose CT thorax
Control subjects will also proceed to CT thorax, and outcome measures be compared to subjects
Control group
Non-lung cancer subjects who are not related any lung cancer patients
Diagnostic test: Low dose CT thorax
A multi-detector row CT scanner with minimum section collimation of ≤1 mm and minimum number of data acquisition channels ≥ 16will be employed.
Diagnostic test: Low dose CT thorax
Control subjects will also proceed to CT thorax, and outcome measures be compared to subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of lung cancer detection in subjects with family history of lung cancer
Time Frame: An average of 2.5 years
The number of screening-detected lung cancer among first degree relatives of lung cancer patients.
An average of 2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The characteristics of screening detected lung cancer
Time Frame: An average of 2.5 years
Stage distribution of lung cancer detected.
An average of 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Kwong Wah Hospital
The Queen Elizabeth Hospital
Hong Kong Sanatorium & Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKU_UW_19_444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The relevant biomarkers from blood and urine sample collected

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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