Retrospective Epidemiological Study of Lung Cancer With Low-dose Multislice Computed Tomography

Lung Cancer Clinical Trial

Official title:

Retrospective Epidemiological Study of Lung Cancer With Low-dose Multislice Computed Tomography (LDCT) - a Screening Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736643
• Other study ID #: 201601052RINB
• Status: Completed
• Start date: April 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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. Epidemiology data for LDCT screening in Taiwan is lacking.

National Taiwan University Hospital Chu-Tung Branch (NTUHCT) 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 establishing local epidemiological result via telephone follow-up and patients' medical records retrospectively.

Description:

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. Epidemiology data for LDCT screening in Taiwan is lacking.

National Taiwan University Hospital Chu-Tung Branch (NTUHCT) 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 establishing local epidemiological result via telephone follow-up and patients' medical records retrospectively.

Aim: To establish the local epidemiological data for lung pathology, emphysema, bronchiectasis and other lung disease.

Methods: Since June 2015, more than 6000 LDCT were done at the NTUHCT. Roughly 6 months after the test telephone follow-ups about patient satisfactions, self-awareness of CT results, medical consultations and other related behaviors, and willingness of coming back for another test were routinely done. Retrospective secondary data analysis will be performed on the telephone follow-up results to establish local epidemiology data on lung pathology as well as information on screening accuracy of LDCT. Customers are also queried about willingness to provide their medical records, and linkage to National Health Insurance Database with informed consents to provide more advanced information on their long-term outcomes.

Keywords: Lung cancer, Low dose computed tomography, screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1334
• Est. completion date: December 31, 2018
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• self pay the LDCT in National Taiwan University Hospital Chu-Tung Branch

Exclusion Criteria:

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal lung finding detection rate	Abnormal lung finding detection rate calculated as (patients with abnormal finding from LDCT / total enrollments).	one month