- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01914458
Image Discovering Early Lung Cancer Project (IDEALCAP)
Low-Dose Computed Tomography for Lung Cancer Screening in High Risk Asymptomatic Patients: the Taiwan Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single center, single arm, non-randomized prospective study. We plan to enroll persons between 50 and 74 years in age, who had cigarette smoking of at least 30 pack-years, and, if former smokers, had quit within the previous 15 years. Persons who had previously received a diagnosis of lung cancer, had undergone chest CT within 18 months before enrollment, had hemoptysis, or had an unexplained weight loss of more than 6.8 kg in the preceding year were excluded.
All the participants should complete a questionnaire that covers many topics, including demographic characteristics and smoking behavior. We also plan to collect additional data for planned analyses of cost-effectiveness, and smoking cessation. Lung-cancer got by biopsy and other biospecimens are available to researchers through a peer-review process All screening examinations are planed to perform in accordance with a standard protocol, developed by medical physicists associated with the trial, that specified acceptable characteristics of the machine and acquisition variables. All low-dose CT scans are acquired with the use of multidetector scanners with a minimum of 16 channels.
IDEALCAP radiologists are certified by appropriate agencies or boards and has completed training in image acquisition; radiologists also has completed training in image quality and standardized image interpretation. Images are interpreted first in isolation and then in comparison with available historical images and images from prior IDEALCAP screening examinations.
IDEALCAP primary analysis is the detection rate of lung cancer. Secondary analysis include the detection rate of lung nodule, 5-year survival rate of persons with lung cancer who receive standard surgical treatment, 5-year survival rate of persons with lung cancer who receive alternative treatment other than standard surgical treatment (ex. Radiotherapy, chemotherapy or target therapy), the correlation of CT images and cigarette smoking history, the correlation of CT images and pulmonary function.
Key Word: low dose computed-tomography (LDCT), lung cancer screening
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chung-Huang Chan, Doctor
- Phone Number: 3030 886-3-9543131
- Email: chchantaipei@gmail.com
Study Contact Backup
- Name: Wei-Chun Lin, Doctor
- Phone Number: 2430 886-3-9543131
- Email: bizzarefish@yahoo.com.tw
Study Locations
-
-
-
Lotung, Taiwan
- Recruiting
- Lotung Pohai General hospital
-
Principal Investigator:
- Chung-Huang Hubert Chan, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 50-74 years
- 30 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low-dose computed tomography (LDCT)
Patients will have one baseline LDCT scan.
|
Low-dose computed tomography scan
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung cancer detection rate
Time Frame: 2 years
|
Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung cancer mortality
Time Frame: 5 years
|
Assess lung cancer mortality in the screened group within next 5 years.
|
5 years
|
All-cause mortality
Time Frame: 5 years
|
Assess all-cause mortality mortality within next 5 years.
|
5 years
|
Nodule detection rate
Time Frame: 3 months
|
Estimate nodule detection rate, types (solid, part-solid, or ground glass opacity) and sizes of lung nodules found.
|
3 months
|
Smoking cessation rate
Time Frame: one year
|
Assess smoking cessation rate in the screened group within next one year.
|
one year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coronary artery calcification
Time Frame: 3 months
|
Estimate coronary artery calcification score (Agatston Score)in the screened group.
|
3 months
|
Incidence rate of cardiovascular accident
Time Frame: 5 years
|
Incidence rate of cardiovascular accident stratified by coronary artery calcification score in the screened group within next 5 years.
|
5 years
|
Diagnosis accuracy of COPD diagnosis by low-dose computed tomography(CT)
Time Frame: 2 years
|
Assess diagnosis accuracy of COPD diagnosis by low-dose computed tomography(CT) (CT emphysema, CT air trapping) according to the reference standard of pulmonary function tests.
|
2 years
|
Lung nodules management
Time Frame: 12 months
|
Assess algorithms for lung nodules management in a regional general hospital in Taiwan.
|
12 months
|
Frequency of diagnostic procedures
Time Frame: 12 months
|
Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed in a regional hospital in Taiwan.
|
12 months
|
Complication of diagnostic procedures
Time Frame: 12 months
|
Assess the complication rate after diagnostic procedures performed after screening in a regional hospital in Taiwan.
Procedures include baseline LDCT.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chung-Huang Hubert Chan, Doctor, CH Chan
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGH-LP101004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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