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Korean Lung Cancer Screening Project (K-LUCAS)

3. januar 2018 opdateret af: Yeol Kim, National Cancer Center, Korea

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

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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

◎ 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

8000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republikken, 10408
        • Rekruttering
        • National Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Yeol Kim, MD, PhD
        • Underforsker:
          • Jaeho Lee, Ph.D
        • Underforsker:
          • Eunju Lee, BSc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

High-risk smoking groups of current smokers and past smokers

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Early stage lung cancer detection rate
Tidsramme: 2 years
2 years
False positive rate
Tidsramme: 2 years
2 years
Cost-effectiveness of screening
Tidsramme: 2 years
Lung cancer screening cost per QALY
2 years
Complications of diagnostic procedure
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participation rate among eligible criteria
Tidsramme: 2 years
2 years
Positve rate of LDCT diagnosis reporting system in Korean population
Tidsramme: 2 years
2 years
Effectiveness of quality control of screening units by network-based, computer-aided detection (CAD) system
Tidsramme: 2 years
Comparing the nodule positive rate and false positive rate between convetional reading process and CAD system
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Center, Korea

Samarbejdspartnere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. april 2017

Primær færdiggørelse (Faktiske)

31. december 2017

Studieafslutning (Forventet)

31. december 2018

Datoer for studieregistrering

Først indsendt

19. december 2017

Først indsendt, der opfyldte QC-kriterier

3. januar 2018

Først opslået (Faktiske)

9. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • klucas2017

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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