Trial Title:
Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration
NCT ID:
NCT05557487
Condition:
Lung Cancer
High-Risk Cancer
Smoking
Pollution; Exposure
Family Relations
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung cancer
Low-dose computed tomography
Real world data
Lung cancer family history
Air pollution
Smoking
Lung cancer risk questionnaire
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Low dose computed tomography
Description:
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.
Arm group label:
First degree relatives of lung cancer patients
Arm group label:
Previous heavy smokers
Arm group label:
With other high-risk occupational or environmental factors
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.
Criteria for eligibility:
Study pop:
High risk population for lung cancer
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
National Taiwan University Hospital Hsin-Chu Branch
Address:
City:
Hsinchu
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chong-Jen Yu, MD PhD
Facility:
Name:
Hualien Tzu Chi Hospital
Address:
City:
Hualien City
Zip:
970473
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chung-Ping Hsu, MD PhD
Facility:
Name:
E-Da Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Yu-Feng Wei, MD PhD
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Inn-Wen Chong, MD PhD
Facility:
Name:
Ministry of Health and Welfare Shuang-Ho Hospital
Address:
City:
New Taipei City
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Po-Hao Feng, MD PhD
Facility:
Name:
Chung Shan Medical University
Address:
City:
Taichung
Zip:
402
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
GEECHEN CHANG, MD, PhD
Phone:
+886-4-24739595
Phone ext:
34414
Email:
geechen@gmail.com
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei city
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chao-Chi Ho, MD PhD
Start date:
December 15, 2022
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Gee-Chen Chang
Agency class:
Other
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
Chung Shan Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557487
