Image Discovering Early Lung Cancer Project

Lung Cancer Clinical Trial

— IDEALCAP  

Official title:

Low-Dose Computed Tomography for Lung Cancer Screening in High Risk Asymptomatic Patients: the Taiwan Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914458
• Other study ID #: CGH-LP101004
• Status: Recruiting
• Phase: Phase 2
• First received: July 28, 2013
• Last updated: July 31, 2013
• Start date: February 2013

Study information

• Verified date: July 2013
• Source: Cathay General Hospital
• Contact: Chung-Huang Chan, Doctor
• Phone: 886-3-9543131
• Email: chchantaipei[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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. We conducted this clinical trial to determine the efficacy of low dose CT in early lung cancer screening in Taiwan.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Low-dose computed tomography (LDCT)
Low-dose computed tomography scan

Locations

Country	Name	City	State
Taiwan	Lotung Pohai General hospital	Lotung

Sponsors (1)

Lead Sponsor	Collaborator
Cathay General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Coronary artery calcification	Estimate coronary artery calcification score (Agatston Score)in the screened group.	3 months	No
Other	Incidence rate of cardiovascular accident	Incidence rate of cardiovascular accident stratified by coronary artery calcification score in the screened group within next 5 years.	5 years	No
Other	Diagnosis accuracy of COPD diagnosis by low-dose computed tomography(CT)	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	No
Other	Lung nodules management	Assess algorithms for lung nodules management in a regional general hospital in Taiwan.	12 months	No
Other	Frequency of diagnostic procedures	Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed in a regional hospital in Taiwan.	12 months	No
Other	Complication of diagnostic procedures	Assess the complication rate after diagnostic procedures performed after screening in a regional hospital in Taiwan. Procedures include baseline LDCT.	12 months	Yes
Primary	Lung cancer detection rate	Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.	2 years	No
Secondary	Lung cancer mortality	Assess lung cancer mortality in the screened group within next 5 years.	5 years	No
Secondary	All-cause mortality	Assess all-cause mortality mortality within next 5 years.	5 years	No
Secondary	Nodule detection rate	Estimate nodule detection rate, types (solid, part-solid, or ground glass opacity) and sizes of lung nodules found.	3 months	No
Secondary	Smoking cessation rate	Assess smoking cessation rate in the screened group within next one year.	one year	No