Retrospective Epidemiological Study of Lung Cancer With L... | NCT02736643

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

NCT02736643

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jan 17, 2019Actual

Enrollment

1,334Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Dec 28, 2017Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Apr 10, 2016

First Submission Date that Met QC Criteria

Apr 10, 2016

First Posted Date

Apr 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2019

Last Update Posted Date

Jan 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

52 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,334Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abnormal lung finding detection rate	Abnormal lung finding detection rate calculated as (patients with abnormal finding from LDCT / total enrollments).	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ding-Cheng Chan, MD, PhD	National Taiwan University Hospital Chu-Tung Branch	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided