LDCT Chest In Assessment Of Apparently Healthy Smokers

Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

To evaluate the effectiveness of LDCT screening in detecting early-stage lung cancers among smokers who do not have symptoms of lung disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Tobacco smoking is the leading preventable cause of death worldwide .Chronic Obstructive Pulmonary Disease (COPD), lung cancer, and cardiovascular disease will be responsible for the majority of deaths in the developed world in the coming decades .

    COPD is characterised by chronic airflow limitation caused by a combination of small airway inflammation and parenchymal destruction (emphysema) . Since computed tomography (CT) has been validated as a non-invasive technique capable of identifying areas of lung parenchyma with emphysema , several studies have identified a subgroup of apparently healthy smokers who have emphysema but no airway obstruction Furthermore, this subgroup has the highest risk of developing lung cancer among smokers .It has been proposed that systemic inflammation may play an important pathogenic role in carcinogenesis . We will conducted this cross sectional study between. current and former smokers without airway obstruction participating in a lung cancer screening study: a study group of smokers with emphysema on the CT, and a control group of smokers without emphysema.

    Study Design

    Study Type:
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Role Of LDCT Chest In Assessment Of Apparently Healthy Smokers
    Anticipated Study Start Date :
    Oct 20, 2023
    Anticipated Primary Completion Date :
    Oct 20, 2024
    Anticipated Study Completion Date :
    Dec 20, 2024

    Outcome Measures

    Primary Outcome Measures

    1. • Prevalence of Emphysema in apparently healthy smoker • Association between lung cancer and emphysema • Rate of early-stage lung cancer detection (Stage I/II) • Lung cancer mortality rate [baseline]

      from LDCT Chest

    Secondary Outcome Measures

    1. Diagnostic accuracy and performance of LDCT • Positive predictive value of LDCT screening • Rate of incidental findings on LDCT requiring follow up • Rate of unnecessary invasive procedures due to false positives [baseline]

      by Statistical tests and anylasis

    Eligibility Criteria


    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Participants have at least 45years old had smoked 10 pack-years or more
    Exclusion Criteria:
    • Age: less than 45 years. Non smoker Evidence of airway obstruction by Pulmonery Function Test

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Assiut University


    • Study Chair: Mustafa sayed, lecture, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Hend Mohamed Sayed Mohamed, Lecture of chest diseases, Assiut University
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • Low Dose CT & healthy smoker
    First Posted:
    Oct 6, 2023
    Last Update Posted:
    Oct 6, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:

    Study Results

    No Results Posted as of Oct 6, 2023