LDCT Screening in Non-smokers in Taiwan

October 10, 2023 updated by: Pan-Chyr Yang, MD, PhD, Academia Sinica, Taiwan

Low Dose Computed Tomography Screening Study in Non-smokers With Risk Factors for Lung Cancer in Taiwan

This study utilizes the low dose computed tomography(LDCT) to detect the occurrence of early lung cancer among non-smokers in Taiwan. Subjects who have family history of lung cancer or have high risk exposures to lung cancer will be recruited to participate LDCT screening and followed up for their possible occurrence of lung cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Lung cancer ranks the No. 1 lethal cancer in Taiwan, with a five-year survival rate (5-yr SR) of only 15%. Most of the patients with early lung cancer are asymptomatic, while 75% of patients with cancer-related symptom at diagnosis have local or distant metastasis. Compared to a 5-yr SR of 70-90% in stage I/II lung cancer, the 5-yr SR in late stage IIIb/IV is less than 15%. Despite the progress in pharmaceutical treatment for late stage disease, early detection is still the only way to improve the outcome and even cure of this potentially lethal disease. Low dose computed tomography (LDCT) in recognized as the best tool available for early diagnosis of lung cancer. However, the radiation exposure, high cost and high false-positive rate are the major concerns to adapt this detection tool to general population. Recent studies from Europe and US have shown that LDCT screening in high-risk cigarette smoking population can effectively reduce lung cancer mortality. However, the major type of lung cancer in Taiwan is adenocarcinoma, which commonly occurs in non-smoker. Therefore, the risk prediction model generated from studies of western countries may not be suitable for directly adapted to our country. LDCT screening for lung cancer detection in non-smoker remains a controversial issue worldwide, including Taiwan. Facing the unmet need, it is urgent to establish the risk assessment model to predict lung cancer risks in non-smokers and to evaluate the efficacy of LDCT screening in non-smoker high-risk population. In this study, we plan to enroll 12000 non-smoker subjects with a given lung cancer risk; half of them should have lung cancer family history. Each participant will receive LDCT at baseline, annually for two years, and biennially for 6 years. Our overall goal is to establish a risk assessment model of lung cancer in non-smokers and provide suggestions to government for considerations for lung cancer prevention and screening policy in Taiwan.

There are three specific aims in our proposed study:

Aim 1: To evaluate the risk assessment model for predicting lung cancer in non-smokers According to the results of LDCT screening, we expect to improve the risk prediction model for nonsmoker female established by GELAC study. The revised risk model will help recognizing higher risk population.

Aim 2: To establish the protocol for LDCT screening pilot study in Taiwan Establishing working protocol and procedures of LDCT screening to assure a homogeneous behavior among study sites

Aim 3: To establish the efficacy of LDCT screening for lung cancer in non-smoker Lung cancer detection rate, false-positive rate, and cost-effectiveness analysis of LDCT screening for non-smoker lung cancer in Taiwan will be established.

Study Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 61363
        • Chiayi Chang Gung Memorial Hospital
      • Hualien City, Taiwan
        • Hualien Tzu Chi Hospital
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung, Taiwan
        • E-DA Cancer Hospital
      • New Taipei City, Taiwan
        • Shuang-Ho Hospital
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Taipei Medical University Hospital
      • Taipei, Taiwan
        • Wan Fang Hospital
      • Taipei, Taiwan, 112
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 33001
        • Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

High risk population for lung cancer

Description

Inclusion Criteria:

  1. Never smokers or have smoked less than 10 pack-years and quitted smoking over 15 years.
  2. age from 55 to 75 years for subjects without lung cancer family history; age 50-75 years for subjects with lung cancer family history (age less than 50 but older than the age at diagnosis of the youngest lung cancer proband is also eligible)
  3. Having at least one of the following conditions:

(1)with family history of lung cancer within 1st, 2nd or 3rd degree relatives (2)with exposure history of environmental tobacco smoke in workplace or in home (3)history of chronic lung disease (Tuberculosis or COPD) (4)the cooking index equal or over than 110 [cooking index = 2/7 x (days of cooking by pan frying, stir frying, or deep frying in one week) x (cooking years)] (5)cooking without using cooking ventilation

Exclusion Criteria:

  1. with history of lung cancer, or with cancers except skin cancer or cervical carcinoma in situ in the past 5 years
  2. can not accept invasive diagnostic procedure or surgery
  3. have been examined by chest computed tomography in the past 18 months
  4. have unexplained hemoptysis in one month
  5. weight loss over than 6 kg with unexplained reason among one year
  6. pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-smokers at risk for lung cancer
  1. Non-smoking subjects with lung cancer family history
  2. Non-smoking subjects with a given lung cancer risk other than lung cancer family history
Other: LDCT
LDCT at enrollment, annually for two years and biennially for 6 years if no lung cancer is detected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of LDCT for lung cancer among non-smokers
Time Frame: 3 years
True positive, false positive, true negative and false negative rates of LDCT on lung cancer screening. Each subject who is recognized as high risk to lung cancer will be recruited between 2014-2016.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring the occurrence of lung cancer
Time Frame: 5 years
Subjects who are recruited between 2014-2016 in this study will be followed every 3-12 months according to their nodule(s) discovered by LDCT for 5 years to obtain their potential occurrence of lung cancer
5 years
Monitoring the recurrence of lung cancer
Time Frame: 5 years
Subjects who have been diagnosed as lung cancer in this study will be monitored for their potential recurrence of lung cancer after clinical treatments/surgery by 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academia Sinica, Taiwan

Collaborators

National Taiwan University Hospital
China Medical University Hospital
Chang Gung Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
National Health Research Institutes, Taiwan
Taichung Veterans General Hospital
Kaohsiung Veterans General Hospital.
Chung Shan Medical University
Ministry of Health and Welfare, Taiwan
Taiwan Lung Cancer Society

Investigators

  • Principal Investigator: Pan-Chyr Yang, M.D., Ph.D., National Taiwan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimated)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS-IRB-BM-15039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on LDCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe