Image Discovering Early Lung Cancer Project
IDEALCAP
Low-Dose Computed Tomography for Lung Cancer Screening in High Risk Asymptomatic Patients: the Taiwan Study
1 other identifier
interventional
600
1 country
1
Brief Summary
Lung cancer is the leading cause of cancer related death in Taiwan and world wide. The application of low dose helical computed tomography (CT) has been the milestone of lung cancer screening. Recently, The National Lung Screening Trial (NLST) shows screening with low-dose CT could reduce mortality from lung cancer. We conducted this clinical trial to determine the efficacy of low dose CT in early lung cancer screening in Taiwan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 28, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedAugust 2, 2013
July 1, 2013
4.9 years
July 28, 2013
July 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lung cancer detection rate
Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.
2 years
Secondary Outcomes (4)
Lung cancer mortality
5 years
All-cause mortality
5 years
Nodule detection rate
3 months
Smoking cessation rate
one year
Other Outcomes (6)
Coronary artery calcification
3 months
Incidence rate of cardiovascular accident
5 years
Diagnosis accuracy of COPD diagnosis by low-dose computed tomography(CT)
2 years
- +3 more other outcomes
Study Arms (1)
Low-dose computed tomography (LDCT)
EXPERIMENTALPatients will have one baseline LDCT scan.
Interventions
Low-dose computed tomography scan
Eligibility Criteria
You may qualify if:
- Age 50-74 years
- or more pack-years of cigarette smoking history
- Former smokers: quit smoking within the previous 15 years
- Ability to tolerate CT procedure
- Signed informed consent
You may not qualify if:
- Severe uncontrolled heart, vascular, respiratory or endocrine pathology.
- Life-expectancy less than 1 year
- History of lung cancer
- Acute respiratory disease
- Hemoptysis.
- Weight loss more than 6.8 kg in the 12 months prior to eligibility assessment
- Participation in other cancer clinical trial
- Chest CT examination in the 12 months prior to eligibility assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lotung Pohai General hospital
Luodong, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung-Huang Hubert Chan, Doctor
CH Chan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- CGHIRB
Study Record Dates
First Submitted
July 28, 2013
First Posted
August 2, 2013
Study Start
February 1, 2013
Primary Completion
January 1, 2018
Last Updated
August 2, 2013
Record last verified: 2013-07