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Trial record 2 of 13 for:    national lung screening trial

Korean Lung Cancer Screening Project (K-LUCAS)

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ClinicalTrials.gov Identifier: NCT03394703
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Korean Association for Lung Cancer
The Korean Society of Radiology
The Korea Academy of Tuberculosis and Respiratory diseases
The Korean Academy of Family Medicine
The Korean Society for Preventive Medicine
Information provided by (Responsible Party):
Yeol Kim, National Cancer Center, Korea

Brief Summary:

Lung cancer is by far the leading cause of cancer death and has a lower relative survival rate than other types of cancer because most lung cancers are detected at an advanced stage when they are first diagnosed.

Recently, a randomized control trial suggests that low-dose computed tomography (LDCT) enables an early stage detection and it has been increasingly accepted as an efficient screening method for high-risk individuals to reduce lung cancer mortality.

In 2011, The National Lung Screening Trial (NLST) in the U.S. has produced results that screening high-risk smoking groups (who have at least 30 pack-year smoking history and currently smoke or have quit within the past 15 years) aged 55 to 74 years with LDCT reduced lung cancer mortality by 20%.

Based on the evidence, Korean National Cancer Center has developed and published the guideline of lung cancer screening using LDCT for high-risk populations in 2015. The guideline recommends annual LDCT screening for high-risk smoking groups aged 55 to 74 years, with at least 30 pack-year smoking history and current smokers or past smokers who quit smoking within 15 years.

The Korean Lung Cancer Screening project (K-LUCAS), a nationwide, multicenter, prospective study started to evaluate the effectiveness and feasibility of lung cancer screening with LDCT for considering implementation of a national lung cancer screening program in Korea.


Condition or disease
Lung Cancer

Detailed Description:

◎ Objective

This study is to evaluate the effectiveness and feasibility of lung cancer screening with LDCT for considering implementation of a national Lung Cancer Screening Program in Korea.

◎ Recruiting procedure

K-LUCAS involves 14 general hospitals located nationwide. The participants in K-LUCAS are recruited from the visitors in these hospitals for receiving national cancer screenings or smoking cessation services. The candidates are evaluated based on the questionnaire that is completed in prior to the national cancer screenings or smoking cessation services. Invitations will be sent to those candidates who meet our selection criteria to take part in LDCT lung cancer screening. Advertising to public including the information both of screening benefit and harm will be held in hospitals, newspaper, local bus stations and subways.

In addition to the criteria-based participant selection, a lung cancer risk prediction model will be adopted to improve the effectiveness of participant selection. The lung cancer risk prediction model considers various lung cancer risk factors in addition to age, smoking history and smoking quit duration which are already examined in the inclusion criteria. The model evaluates drinking amount, physical activity, family history of cancer, past history of lung disease and so on, in participant selection.

◎ Screening procedure

If the candidate meets the selection criteria or is approved by risk prediction model, investigators carefully explain the benefits or harms of the LDCT screening and offer them to participate in a LDCT lung cancer screening. If the candidate agrees on screening participation, an informed consent form is obtained and LDCT screening date is scheduled and confirmed. K-LUCAS also provides a smoking cessation counselling to current smokers on revisiting for the result counselling. A follow-up call is made after 6 months from the LDCT screening in order to assess smoking cessation status following LDCT screening.

◎Reporting LDCT results

The LDCT screening results are evaluated by radiologists in accordance with Lung imaging reporting and data system (Lung-RADS).

Network-based computer-aided detection (CAD) system will be used in K-LUCAS to assist reducing diagnostic errors and increasing lung nodule detection sensitivity.


Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Korean Lung Cancer Screening Project for High-risk Smokers to Evaluate Effectiveness and Feasibility of Lung Cancer Screening With Low-dose Computed Tomography for Implementing National Cancer Screening Program
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Early stage lung cancer detection rate [ Time Frame: 2 years ]
  2. False positive rate [ Time Frame: 2 years ]
  3. Cost-effectiveness of screening [ Time Frame: 2 years ]
    Lung cancer screening cost per QALY

  4. Complications of diagnostic procedure [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Participation rate among eligible criteria [ Time Frame: 2 years ]
  2. Positve rate of LDCT diagnosis reporting system in Korean population [ Time Frame: 2 years ]
  3. Effectiveness of quality control of screening units by network-based, computer-aided detection (CAD) system [ Time Frame: 2 years ]
    Comparing the nodule positive rate and false positive rate between convetional reading process and CAD system



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
High-risk smoking groups of current smokers and past smokers
Criteria

We select participants based on the following criteria.

  • Inclusion Criteria (1)

    • Age : 55-74 years old
    • Smoking history of at least 30 pack-years

      1. current smokers
      2. past smokers who quit smoking within 15 years
  • Inclusion Criteria (2) The lung cancer risk prediction model considers various lung risk factors in addition to age, smoking history and smoking quit duration. This includes drinking amount, physical activity, family history of cancer, information on lung disease and so on, in participant selection. Following criteria is applied when the lung cancer risk prediction model is used for participant selection.

    • Age : 50-74 years old
    • Smoking history of at least 20 pack-years

      1. current smokers
      2. past smokers who quit smoking within 15 years
  • Exclusion Criteria:

    • Lung cancer diagnosed and treated
    • Inability to move without help (ECOG status 2 or higher)
    • Have been treating regularly for tuberculosis, pneumonia and interstitial lung disease
    • Treated for any cancer within the last 5 years (*Exception: Thyroid cancer, Skin cancer)
    • A chest CT examination less than 6 months

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): NCT03394703


Contacts
Contact: Yeol Kim, MD, PhD 82-31-920-1753 drheat@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang, Gyeonggi, Korea, Republic of, 10408
Contact: Yeol Kim, MD, PhD    82-31-920-1753    drheat@ncc.re.kr   
Principal Investigator: Yeol Kim, MD, PhD         
Sub-Investigator: Jaeho Lee, Ph.D         
Sub-Investigator: Eunju Lee, BSc         
Sponsors and Collaborators
National Cancer Center, Korea
Korean Association for Lung Cancer
The Korean Society of Radiology
The Korea Academy of Tuberculosis and Respiratory diseases
The Korean Academy of Family Medicine
The Korean Society for Preventive Medicine

Additional Information:
Publications:

Responsible Party: Yeol Kim, Principal investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT03394703     History of Changes
Other Study ID Numbers: klucas2017
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yeol Kim, National Cancer Center, Korea:
Lung cancer
screening
Low-dose Computed Tomography
Smokers

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