Clinical trial NCT06070922: LDCT Chest In Assessment Of Apparently Healthy Smokers
Official title: Role Of LDCT Chest In Assessment Of Apparently Healthy Smokers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Smoking
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After taking the informed consent, full history will be taken from all patients participating in the study include smoking history. Detailed clinical examination and routine laboratory investigations will be done.

Low Dose CT chest( reduced the radiation exposure to 1.6 mSv ) will be done . Spirometry spirometry will be performed using standard techniques according to ATS-ERS criteria 2019 .

These individuals will further classified into two groups according to the presence or absence of emphysema on the LDCT, the study group have smokers and former smokers with emphysema on the LDCT but no evidence of airway obstruction, whereas the comparison group current and former smokers without emphysema and without obstruction

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.

Eligibility criteria: 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

Primary outcomes:
measure: • 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
timeFrame: baseline
Secondary outcomes:
measure: 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
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mustafa sayed, lecture
role: STUDY_CHAIR
References:
citation: Koyama H, Ohno Y, Yamazaki Y, Matsumoto K, Onishi Y, Takenaka D, Yoshikawa T, Nishio M, Matsumoto S, Murase K, Nishimura Y, Sugimura K. Reduced-dose chest CT with 3D automatic exposure control vs. standard chest CT: quantitative assessment of emphysematous changes in smokers' lung parenchyma. Eur J Radiol. 2012 Jun;81(6):1330-4. doi: 10.1016/j.ejrad.2011.03.037. Epub 2011 Jun 24.
citation: Bonney A, Malouf R, Marchal C, Manners D, Fong KM, Marshall HM, Irving LB, Manser R. Impact of low-dose computed tomography (LDCT) screening on lung cancer-related mortality. Cochrane Database Syst Rev. 2022 Aug 3;8(8):CD013829. doi: 10.1002/14651858.CD013829.pub2.