Clinical trial NCT05557487: Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration
Official title: Taiwan Real-world Low-dose Computed Tomography Screening BehavIor and Outcome Research for High Risk Subjects Based on Health Promotion Administration-part A: Questionnaire Survey -part B: LDCT Screening Outcome and Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2022-09-28
Enrollment: 6618
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High risk population for lung cancer

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.


Eligibility criteria: Inclusion Criteria:

Group 1: Previous heavy smokers Age 50 to 80 years, meet both criteria in the followings.

1. Cigarette smoking of at least 20 pack-years
2. 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

1. aged more than 50 years
2. 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.

1. air-pollution exposed occupations (such as traffic policemen, and 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 intervals more than 5 years before this study

Exclusion Criteria:

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

Primary outcomes:
measure: The rate of willingness and completeness of LDCT screening after the detailed questionnaire survey for the eligible participants.
timeFrame: 2 years
measure: To investigate overall lung cancer detection rate of high lung cancer risk individuals
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Ministry of Health and Welfare Shuang-Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
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citation: 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.