Lung CancerPhase 2IDEALCAPNCT01914458
Image Discovering Early Lung Cancer Project
A Phase 2 study testing Low-dose computed tomography (LDCT) in people with Lung Cancer, run by Cathay General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Low-dose computed tomography (LDCT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2013to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Lotung Pohai General hospital
Luodong
Chung-Huang Hubert Chan, Doctor
About this study
Official title: Low-Dose Computed Tomography for Lung Cancer Screening in High Risk Asymptomatic Patients: the Taiwan Study
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.
Read the 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
- Conditions
- Lung Cancer
- Being tested
- Low-dose computed tomography (LDCT)
- Keywords
- Lung cancer, Low-dose computed tomography scan
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose computed tomography (LDCT)Procedure or surgery
Also called LDCT scan
Low-dose computed tomography scan
| Study group | Role | What they receive |
|---|---|---|
| Low-dose computed tomography (LDCT) | Experimental | Patients will have one baseline LDCT scan. Receives: Procedure: Low-dose computed tomography (LDCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer detection rate
Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.
Measured: 2 years
Secondary outcomes (4)
Lung cancer mortality
Assess lung cancer mortality in the screened group within next 5 years.
Measured: 5 years
All-cause mortality
Assess all-cause mortality mortality within next 5 years.
Measured: 5 years
Nodule detection rate
Estimate nodule detection rate, types (solid, part-solid, or ground glass opacity) and sizes of lung nodules found.
Measured: 3 months
Smoking cessation rate
Assess smoking cessation rate in the screened group within next one year.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathay General Hosp. IRB, Cathay General Hospital
- Investigators
- Chung-Huang Hubert Chan, Doctor, Principal investigator, CH Chan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914458
- Sponsor's protocol ID
- CGH-LP101004
- Acronym
- IDEALCAP
- Status last verified
- Jul 2013
- First submitted
- 28 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Computed Tomography for Lung Cancer Screening in High Risk Asymptomatic Patients: the Taiwan Study
- ClinicalTrials.gov ID
- NCT01914458
- Acronym / sponsor ID
- IDEALCAP / CGH-LP101004
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Low-dose computed tomography scan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2018 (estimated)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose computed tomography (LDCT) | Experimental | Procedure: Low-dose computed tomography (LDCT)Patients will have one baseline LDCT scan. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Severe uncontrolled heart, vascular, respiratory or endocrine pathology.
- Life-expectancy less than 1 year
- History of lung cancer
- Acute respiratory disease
- Hemoptysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose computed tomography (LDCT)Also: LDCT scanLow-dose computed tomography scan | Procedure or surgery | Low-dose computed tomography (LDCT) |
Primary outcome
Lung cancer detection rate
Time frame: 2 years
Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.
4 secondary outcomes
Lung cancer mortality
Time frame: 5 years
All-cause mortality
Time frame: 5 years
Nodule detection rate
Time frame: 3 months
Smoking cessation rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Huang Hubert Chan, Doctor principal investigator
CH Chan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose computed tomography (LDCT) in people with Lung Cancer, run by Cathay General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung-Huang Chan, Doctor (886-3-9543131 ext. 3030, chchantaipei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer detection rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.