Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05557487
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-09-23
Brief Title:
Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration
Sponsor:
Gee-Chen Chang
Organization:
Chung Shan Medical University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIO
Brief Summary:
Lung cancer is the leading cause of mortality in the world and also in TaiwanDespite 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 mutationsIn 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 27 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 11 for group 1 based on NLST results16 26 for group 2 395 out of 12011 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
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 11 for group 1 based on NLST results16 26 for group 2 395 out of 12011 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None