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

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ClinicalTrials.gov Identifier: NCT02736643
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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. 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.


Condition or disease
Lung Cancer

Detailed 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 1334 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 52 Weeks
Official Title: Retrospective Epidemiological Study of Lung Cancer With Low-dose Multislice Computed Tomography (LDCT) - a Screening Program
Study Start Date : April 2016
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Abnormal lung finding detection rate [ Time Frame: one month ]
    Abnormal lung finding detection rate calculated as (patients with abnormal finding from LDCT / total enrollments).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
self pay the LDCT in National Taiwan University Hospital Chu-Tung Branch
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736643


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ding-Cheng Chan, MD, PhD National Taiwan University Hospital Chu-Tung Branch

Additional Information:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02736643     History of Changes
Other Study ID Numbers: 201601052RINB
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Taiwan University Hospital:
LDCT, screening
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases