LDCT Chest In Assessment Of Apparently Healthy Smokers

NCT06070922 | Unknown DMC

• 1 other identifier: Low Dose CT & healthy smoker
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (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

  from LDCT Chest

  baseline

Secondary Outcomes (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

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- Participants have at least 45years old had smoked 10 pack-years or more

You may not qualify if:

• Age: less than 45 years. Non smoker Evidence of airway obstruction by Pulmonery Function Test

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 21703788 BACKGROUND

• 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.

  PMID: 35921047 BACKGROUND

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mustafa sayed, lecture

  Assiut University

  STUDY CHAIR

Central Study Contacts

Hend saleh, lecture

CONTACT

01098988712; hend.m.saleh@gmail.com

samiaa mohamed, professor

CONTACT

01006769597; Samiaa2023@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture of chest diseases

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 6, 2023
• Study Start: October 20, 2023
• Primary Completion: October 20, 2024
• Study Completion: December 20, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10