SmokingNCT06070922
LDCT Chest In Assessment Of Apparently Healthy Smokers
An observational study of Smoking, run by Assiut University.
Trial summary
To evaluate the effectiveness of LDCT screening in detecting early-stage lung cancers among smokers who do not have symptoms of lung disease. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Participants have at least 45years old had smoked 10 pack-years or more
Who cannot join
- Age: less than 45 years. Non smoker Evidence of airway obstruction by Pulmonery Function Test
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking
- Medical subject headings
- Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 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
by Statistical tests and anylasis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
- Investigators
- Mustafa sayed, lecture, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070922
- Sponsor's protocol ID
- Low Dose CT & healthy smoker
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21703788Bonney 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.
PubMed 35921047
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of LDCT Chest In Assessment Of Apparently Healthy Smokers
- ClinicalTrials.gov ID
- NCT06070922
- Acronym / sponsor ID
- Low Dose CT & healthy smoker
- Conditions
- Smoking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Participants have at least 45years old had smoked 10 pack-years or more
Key exclusion criteria (1 listed)
- Age: less than 45 years. Non smoker Evidence of airway obstruction by Pulmonery Function Test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• 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
Time frame: baseline
from LDCT Chest
1 secondary outcome
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
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 21703788Koyama 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.
- Background: PubMed 35921047Bonney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa sayed, lecture study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend saleh, lecture (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06070922, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.