NCT02754388

Brief Summary

Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought to be the best screening tool for lung cancer. However, there is growing concerns about radiation exposure, high cost, and high rate of false-positive screening result. Epidemiologic studies from western countries showed that cigarette smoking is the major cause of lung cancer, and other risk factors may include age, environmental pollution, occupational exposures (included of radon exposure), gender, race, and pre-existing lung diseases. Adenocarcinoma is the major type of lung cancer in Taiwan and is less attributable to smoking. The investigators need a different risk prediction model adapted to the investigators country. National Taiwan University Hospital Chu-Tung Branch initiated the lung cancer screening by LDCT since June 2015. Many people can get the LDCT screening with affordable price with the subsidy from enterprise donation. The purpose of this study is observing those participants with 2-year follow-up. Furthermore, those data may connect with another study of "Low dose computed tomography screening study in nonsmoker with risk factors for lung cancer in Taiwan" (Non-smoker study)which is implemented in other hospitals in Taiwan.For reality limiting, After one year, the enrollment rate was a lot lower than expected. We extended the enrollment time but only observe those participants for one year not two year..

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

April 10, 2016

Last Update Submit

February 27, 2020

Conditions

Keywords

LDCT, screening, health behavior, psychological factors

Outcome Measures

Primary Outcomes (1)

  • Abnormal ct finding detection rate

    Abnormal ct finding detection rate is defined as number of abnormal ct finding/total enroll number

    1-month

Secondary Outcomes (2)

  • Change in Chinese 14-item Perceived Stress Scale (Chinese 14-item PSS) score

    6-month

  • Change in Chinese Health Questionnaire-12 (CHQ-12) score

    12-month

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients received LDCT screening at NTUH Chu-Tung Branch

You may qualify if:

  • age\>=20
  • self pay the LDCT in National Taiwan University Hospital Chu-Tung Branch
  • ability to understand the informed consent form for complete the questionnaires
  • be willing and able to accept telephone access at the time scheduled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsHealth Behavior

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Ding-Cheng Chan, MD, PhD

    National Taiwan University Hospital Chu-Tung Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
52 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2016

First Posted

April 28, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2019

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share