NCT05762731

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

February 14, 2023

Last Update Submit

March 6, 2023

Conditions

Keywords

Lung cancerScreeningFamily history

Outcome Measures

Primary Outcomes (1)

  • The rate of lung cancer detection in subjects with family history of lung cancer

    The number of screening-detected lung cancer among first degree relatives of lung cancer patients.

    An average of 2.5 years

Secondary Outcomes (1)

  • The characteristics of screening detected lung cancer

    An average of 2.5 years

Study Arms (2)

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

Control group

Non-lung cancer subjects who are not related any lung cancer patients

Diagnostic Test: Low dose CT thorax

Interventions

Low dose CT thoraxDIAGNOSTIC_TEST

A multi-detector row CT scanner with minimum section collimation of ≤1 mm and minimum number of data acquisition channels ≥ 16will be employed.

First degree relatives of lung cancer patients

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Non-Chinese
  • Mentally incompetent to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, 0, Hong Kong

RECRUITING

Related Publications (20)

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    PMID: 24004119BACKGROUND
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  • Field JK, Aberle DR, Altorki N, Baldwin DR, Dresler C, Duffy SW, Goldstraw P, Hirsch FR, Pedersen JH, de Koning HJ, Mulshine JL, Sullivan DC, Tsao MS, Travis WD; International Association for the Study of Lung Cancer Strategic Screening Advisory Committee. The International Association Study Lung Cancer (IASLC) Strategic Screening Advisory Committee (SSAC) response to the USPSTF recommendations. J Thorac Oncol. 2014 Feb;9(2):141-3. doi: 10.1097/JTO.0000000000000060. No abstract available.

    PMID: 24419409BACKGROUND
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    PMID: 23425165BACKGROUND
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    PMID: 22436981BACKGROUND
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    PMID: 18780872BACKGROUND
  • Wu AH, Fontham ET, Reynolds P, Greenberg RS, Buffler P, Liff J, Boyd P, Correa P. Family history of cancer and risk of lung cancer among lifetime nonsmoking women in the United States. Am J Epidemiol. 1996 Mar 15;143(6):535-42. doi: 10.1093/oxfordjournals.aje.a008783.

    PMID: 8610670BACKGROUND
  • Amos CI, Pinney SM, Li Y, Kupert E, Lee J, de Andrade MA, Yang P, Schwartz AG, Fain PR, Gazdar A, Minna J, Wiest JS, Zeng D, Rothschild H, Mandal D, You M, Coons T, Gaba C, Bailey-Wilson JE, Anderson MW. A susceptibility locus on chromosome 6q greatly increases lung cancer risk among light and never smokers. Cancer Res. 2010 Mar 15;70(6):2359-67. doi: 10.1158/0008-5472.CAN-09-3096. Epub 2010 Mar 9.

    PMID: 20215501BACKGROUND
  • Li X, Hemminki K. Inherited predisposition to early onset lung cancer according to histological type. Int J Cancer. 2004 Nov 10;112(3):451-7. doi: 10.1002/ijc.20436.

    PMID: 15382071BACKGROUND
  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

    PMID: 21714641BACKGROUND
  • Field JK, Duffy SW. Lung cancer CT screening: are we ready to consider screening biennially in a subgroup of low-risk individuals? Thorax. 2018 Nov;73(11):1006-1007. doi: 10.1136/thoraxjnl-2018-211814. Epub 2018 Jun 28. No abstract available.

    PMID: 29954858BACKGROUND
  • Walter JE, Heuvelmans MA, Bock GH, Yousaf-Khan U, Groen HJM, Aalst CMV, Nackaerts K, Ooijen PMAV, Koning HJ, Vliegenthart R, Oudkerk M. Characteristics of new solid nodules detected in incidence screening rounds of low-dose CT lung cancer screening: the NELSON study. Thorax. 2018 Aug;73(8):741-747. doi: 10.1136/thoraxjnl-2017-211376. Epub 2018 Apr 16.

    PMID: 29661918BACKGROUND
  • MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23.

    PMID: 28240562BACKGROUND
  • McKee BJ, Hashim JA, French RJ, McKee AB, Hesketh PJ, Lamb CR, Williamson C, Flacke S, Wald C. Experience With a CT Screening Program for Individuals at High Risk for Developing Lung Cancer. J Am Coll Radiol. 2016 Feb;13(2 Suppl):R8-R13. doi: 10.1016/j.jacr.2015.12.006.

    PMID: 26846536BACKGROUND
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    PMID: 27521737BACKGROUND
  • McWilliams A, Tammemagi MC, Mayo JR, Roberts H, Liu G, Soghrati K, Yasufuku K, Martel S, Laberge F, Gingras M, Atkar-Khattra S, Berg CD, Evans K, Finley R, Yee J, English J, Nasute P, Goffin J, Puksa S, Stewart L, Tsai S, Johnston MR, Manos D, Nicholas G, Goss GD, Seely JM, Amjadi K, Tremblay A, Burrowes P, MacEachern P, Bhatia R, Tsao MS, Lam S. Probability of cancer in pulmonary nodules detected on first screening CT. N Engl J Med. 2013 Sep 5;369(10):910-9. doi: 10.1056/NEJMoa1214726.

    PMID: 24004118BACKGROUND
  • Lam DC, Tam TC, Lau KM, Wong WM, Hui CK, Lam JC, Wang JK, Lui MM, Ho JC, Ip MS. Plasma EGFR Mutation Detection Associated With Survival Outcomes in Advanced-Stage Lung Cancer. Clin Lung Cancer. 2015 Nov;16(6):507-13. doi: 10.1016/j.cllc.2015.06.003. Epub 2015 Jun 24.

    PMID: 26239567BACKGROUND
  • Bujang MA, Adnan TH. Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis. J Clin Diagn Res. 2016 Oct;10(10):YE01-YE06. doi: 10.7860/JCDR/2016/18129.8744. Epub 2016 Oct 1.

    PMID: 27891446BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine samples

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

March 10, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

March 10, 2023

Record last verified: 2023-01

Locations