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Image Discovering Early Lung Cancer Project (IDEALCAP)

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ClinicalTrials.gov Identifier: NCT01914458
Recruitment Status : Unknown
Verified July 2013 by Cathay General Hosp. IRB, Cathay General Hospital.
Recruitment status was:  Recruiting
First Posted : August 2, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Cathay General Hosp. IRB, Cathay General Hospital

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Low-dose computed tomography (LDCT) Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Low-Dose Computed Tomography for Lung Cancer Screening in High Risk Asymptomatic Patients: the Taiwan Study
Study Start Date : February 2013
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-dose computed tomography (LDCT)
Patients will have one baseline LDCT scan.
Procedure: Low-dose computed tomography (LDCT)
Low-dose computed tomography scan
Other Name: LDCT scan




Primary Outcome Measures :
  1. Lung cancer detection rate [ Time Frame: 2 years ]
    Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.


Secondary Outcome Measures :
  1. Lung cancer mortality [ Time Frame: 5 years ]
    Assess lung cancer mortality in the screened group within next 5 years.

  2. All-cause mortality [ Time Frame: 5 years ]
    Assess all-cause mortality mortality within next 5 years.

  3. 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.

  4. Smoking cessation rate [ Time Frame: one year ]
    Assess smoking cessation rate in the screened group within next one year.


Other Outcome Measures:
  1. Coronary artery calcification [ Time Frame: 3 months ]
    Estimate coronary artery calcification score (Agatston Score)in the screened group.

  2. 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.

  3. 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.

  4. Lung nodules management [ Time Frame: 12 months ]
    Assess algorithms for lung nodules management in a regional general hospital in Taiwan.

  5. 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.

  6. 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.



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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01914458


Contacts
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Contact: Chung-Huang Chan, Doctor 886-3-9543131 ext 3030 chchantaipei@gmail.com
Contact: Wei-Chun Lin, Doctor 886-3-9543131 ext 2430 bizzarefish@yahoo.com.tw

Locations
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Taiwan
Lotung Pohai General hospital Recruiting
Lotung, Taiwan
Principal Investigator: Chung-Huang Hubert Chan, Doctor         
Sponsors and Collaborators
Cathay General Hospital
Investigators
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Principal Investigator: Chung-Huang Hubert Chan, Doctor CH Chan

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Responsible Party: Cathay General Hosp. IRB, CGHIRB, Cathay General Hospital
ClinicalTrials.gov Identifier: NCT01914458     History of Changes
Other Study ID Numbers: CGH-LP101004
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2013

Keywords provided by Cathay General Hosp. IRB, Cathay General Hospital:
Lung cancer
Low-dose computed tomography scan

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases