LDCT Chest In Assessment Of Apparently Healthy Smokers

Not yet recruiting

• Conditions: Smoking

• Registration Number: NCT06070922
• Lead Sponsor: Assiut University

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.

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 Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-01
• Study First Submitted QC: 2023-10-05
• Last Update Submitted: 2023-10-05
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06
• Study Start: 2023-10-20
• Primary Completion: 2024-10-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• 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

Name	Time	Method
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