LDCT Chest In Assessment Of Apparently Healthy Smokers

Role Of LDCT Chest In Assessment Of Apparently Healthy Smokers

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

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Hend saleh, lecture; Phone Number: 01098988712; Email: hend.m.saleh@gmail.com
• Study Contact Backup: Name: samiaa mohamed, professor; Phone Number: 01006769597; Email: Samiaa2023@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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	from LDCT Chest	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	by Statistical tests and anylasis	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mustafa sayed, lecture, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: October 1, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Low Dose CT & healthy smoker

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No