Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration

NCT05557487 | Recruiting

• 1 other identifier: CS1-22111
• Study Type: observational
• Target: 6,618
• Locations: 1 country
• Sites: 7

Brief Summary

Lung cancer is the leading cause of mortality in the world, and also in Taiwan.Despite the researches and availability in new therapies, it causes the highest mortality and is one of the most preventable cancers as well. Smoking is the most common cause of lung cancer worldwide. Compared to lung cancer in smokers, lung cancer in never-smokers is associated with East Asian ethnicity, female sex, and adenocarcinoma histology. This unique risk group is likely to have distinct molecular drivers, especially EGFR, ALK, and ROS1 mutations.In National Taiwan Cancer Registry data, more than half (53%) of all newly diagnosed lung cancer patients and 93% of female patients are lifelong never-smokers. This scenario is common in East Asia. It is essential to develop a different strategy for screening lung cancer patients with other high-risk profiles. Several risk factors have been identified in never-smoking lung cancer and one of the most important factor is a lung cancer family history (LCFH) in a first-degree relative. Other high-risk occupational or environmental factors include air-pollution exposed occupations (such as traffic policeman and street cleaners) for at least 10 years, cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir frying, or deep frying in one week \* years cooking, cooking without using ventilation, passive smoke exposure, and history of pulmonary tuberculosis or chronic obstructive pulmonary disorders. As described above, three high risk groups are interested in this study, the previous heavy smokers (group 1); those who has family history (group 2) and those who have high risk occupation or environment factors (group 3). From the published researches, we assume the detection rate to be 1.1% for group 1 based on NLST results16, 2.6% for group 2 (395 out of 12,011 subjects in TALENT), and we assume the detection Group 3 to be 1% after consulting board-certified senior specialists in this field. This is a prospective, multi-center, single arm study in Taiwan of subjects who are eligible to receive LDCT screening based on recommendation of Health Promotion Administration of Taiwan. The primary objective of TRIO part A is the LDCT screening acceptance rate of high lung cancer risk subjects. The primary objective of TRIO part B is the exact lung cancer detection rates in these three groups. Other secondary objectives are also included.

Conditions

Lung Cancer; High-Risk Cancer; Smoking; Pollution; Exposure; Family Relations

Keywords

Lung cancer; Low-dose computed tomography; Real world data; Lung cancer family history; Air pollution; Smoking; Lung cancer risk questionnaire

Outcome Measures

Primary Outcomes (2)

• The rate of willingness and completeness of LDCT screening after the detailed questionnaire survey for the eligible participants.

  1. Eligible participants must meet the inclusion and exclusion criteria of this study 2. Only the one who completes the detailed questionnaire survey is counted.

  2 years

• To investigate overall lung cancer detection rate of high lung cancer risk individuals

  Cytological or Pathological proof of lung cancer to investigate the overall lung cancer detection rate

  2 years

Study Arms (3)

Previous heavy smokers

Age 40 to 80 years who have at least a 20-pack-year smoking history with successful smoking cessation history (stopping smoking for more than 6 months), but less than 15 years

Diagnostic Test: Low dose computed tomography

First degree relatives of lung cancer patients

First-degree relatives of lung cancer patients 1. aged more than 40 years 2. age less than 40 years old, but older than the age at diagnosis of the youngest lung cancer proband in the family

Diagnostic Test: Low dose computed tomography

With other high-risk occupational or environmental factors

Age 40 to 80 years, meet one or more of the following criteria. 1. air-pollution exposed occupations (such as traffic policeman, street cleaners….) for at least 10 years 2. cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir frying, or deep frying in one week \* years cooking. 3. cooking without using ventilation for more than 20 years 4. history of pulmonary tuberculosis and complete anti-tuberculosis treatment with interval more than 5 years before this study

Diagnostic Test: Low dose computed tomography

Interventions

Low dose computed tomography DIAGNOSTIC_TEST

1. Participants belonging to modified Lung RADS category 1 and 2 at baseline screening will undergo the LDCT next year after the discussion with the physicians in charge. 2. Participants with nodules belonging to modified Lung RADS category 3 and 4, growing nodules, or new nodules found on follow-up LDCT scans will undergo repeat CT every 3 to 6 months or be referred for diagnostic workup depending on the size and characteristics of the nodules as the regular clinical practice. 3. Volume doubling time (VDT) will be performed in the special groups with Lung RADS category 3 or 4, but the nodules with solid components ≧ 6mm and \< 9mm. A repeat LDCT scan will be performed around 3 months after the baseline screening. 4. Check total bilirubin, urinary heavy metals,CRP, serum tumor marker, including CEA, alpha-fetal protein, etc. 5. Check pulmonary function test.

First degree relatives of lung cancer patients; Previous heavy smokers; With other high-risk occupational or environmental factors

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High risk population for lung cancer

You may qualify if:

• Group 1: Previous heavy smokers Age 50 to 80 years, meet both criteria in the followings.
• Cigarette smoking of at least 20 pack-years
• With successful smoking cessation history (stopping smoking for more than 6 months), but less than 15 years
• Group 2: First-degree relatives of lung cancer patients
• aged more than 50 years
• age less than 50 years old, but older than the age at diagnosis of the youngest lung cancer proband in the family
• Group 3: With other high-risk occupational or environmental factors Age 50 to 80 years, meet one or more of the following criteria.
• air-pollution exposed occupations (such as traffic policemen, and street cleaners….) for at least 10 years
• cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir-frying, or deep frying in one week \* years cooking.
• cooking without using ventilation for more than 20 years
• history of pulmonary tuberculosis and complete anti-tuberculosis treatment with intervals more than 5 years before this study

You may not qualify if:

• previous history of lung cancer
• another malignancy except for cervical carcinoma in situ or non-melanomatous carcinoma of the skin within 5 years
• an inability to tolerate transthoracic procedures or thoracotomy
• chest CT examination was performed within 18 months
• hemoptysis of unknown etiology within one month
• body weight loss of more than 6 kg within one year without an evident cause
• a known pregnancy
• Not capable of understanding or responding to the written questionnaire even through the help from the study team

Sponsors & Collaborators

• Gee-Chen Chang: lead
• AstraZeneca: collaborator

Study Sites (7)

Chung Shan Medical University

Taichung, Taiwan, 402, Taiwan

RECRUITING

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

Hualien Tzu Chi Hospital

Hualien City, 970473, Taiwan

RECRUITING

E-Da Hospital

Kaohsiung City, Taiwan

NOT YET RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (6)

• Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

  PMID: 25651787 BACKGROUND

• National Lung Screening Trial Research Team; Church TR, Black WC, Aberle DR, Berg CD, Clingan KL, Duan F, Fagerstrom RM, Gareen IF, Gierada DS, Jones GC, Mahon I, Marcus PM, Sicks JD, Jain A, Baum S. Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013 May 23;368(21):1980-91. doi: 10.1056/NEJMoa1209120.

  PMID: 23697514 BACKGROUND

• Patz EF Jr, Pinsky P, Gatsonis C, Sicks JD, Kramer BS, Tammemagi MC, Chiles C, Black WC, Aberle DR; NLST Overdiagnosis Manuscript Writing Team. Overdiagnosis in low-dose computed tomography screening for lung cancer. JAMA Intern Med. 2014 Feb 1;174(2):269-74. doi: 10.1001/jamainternmed.2013.12738.

  PMID: 24322569 BACKGROUND

• US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Landefeld CS, Li L, Ogedegbe G, Owens DK, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Mar 9;325(10):962-970. doi: 10.1001/jama.2021.1117.

  PMID: 33687470 BACKGROUND

• Kim H, Kim HY, Goo JM, Kim Y. Lung Cancer CT Screening and Lung-RADS in a Tuberculosis-endemic Country: The Korean Lung Cancer Screening Project (K-LUCAS). Radiology. 2020 Jul;296(1):181-188. doi: 10.1148/radiol.2020192283. Epub 2020 Apr 14.

  PMID: 32286195 BACKGROUND

• de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29.

  PMID: 31995683 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood samples, urine samples, lung tissue samples.

MeSH Terms

Conditions

Lung Neoplasms; Smoking

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Central Study Contacts

GeeChen Chang, MD. PhD

CONTACT

+886-4-24739595; geechen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chung Shan Medical University

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: December 15, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

TW (7)