Patient ParticipationNCT05475977
Role of MSCT of Chest in Differentiation Between COPD Patients According to Their Smoking Status
An observational study of Patient Participation, run by Somaia Ahmad AbdAllah Ahmad.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality all over the world. Smoking is considered as an important risk factor, but other risk factors are present. Around 30 % of patients with COPD are non-smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Participation
- What is being tested?
- MSCT chest
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jul 2023
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients either smokers, ex-smokers or non-smokers
Who may be able to join
- All patients with chronic obstructive Pulmonary Disease.
- Patients above 18 years.
Who cannot join
- Patients with unclear smoking history.
- Patients with active pneumonia.
- Patients with acute COPD exacerbation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Multislice Computed Tomography (MSCT) Chest in Differentiation Between Chronic Obstructive Pulmonary Disease(COPD) Patients According to Their Smoking Status
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality all over the world. Smoking is considered as an important risk factor, but other risk factors are present. Around 30 % of patients with COPD are non-smokers.
Cessation of smoking in patients with COPD causes decreases the presence of micronodules and other criteria of CT chest.
Read more
In last few years, some researchers reported that cessation of smoking raise the apparent extent of emphysema. The cause is not obvious, but this paradoxical fall in lung density is thaught to be resulting from decrease in inflammation after smoking cessation.
CT chest criteria of COPD in active smokers, non-smokers and ex-smokers seem to be different.
So, comparison between CT chest Criteria of COPD in smokers, ex-smokers and non-smokers will be searched in this study to detect the role of multislice computed tomography (MSCT) chest in differentiation between COPD patients according to their smoking status.
Read the detailed description
Basic ethical principles of medical research; beneficence (do well), non-maleficence (do no harm), respect and distributive justice were implemented. The study will be carried out in accordance with the Declaration of Helsinki and the principles of good clinical practice.
- Conditions
- Patient Participation
- Being tested
- MSCT chest
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCT chestDiagnostic test
Multi slice Computed Tomography of the chest
| Study group | Role | What they receive |
|---|---|---|
| First Group | Thirty patients of COPD smokers patients. Receives: Diagnostic Test: MSCT chest | |
| Second group | Thirty patients of COPD ex-smokers patients. Receives: Diagnostic Test: MSCT chest | |
| Third group | Thirty patients of COPD non-smokers patients. Receives: Diagnostic Test: MSCT chest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with criteria of severe COPD
Criteria of severe COPD include emphysematous bullae, thick bronchial walls.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ParticipationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Somaia Ahmad AbdAllah Ahmad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Somaia Ahmad AbdAllah Ahmad, Assiut University
- Investigators
- Somaia Ahmad AbdAllah Ahmad, M.B.B.Ch, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475977
- Sponsor's protocol ID
- Somaia Ahmad
- Status last verified
- Aug 2022
- First submitted
- 28 Jun 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: COPD MSCT criteria smoking status
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Multislice Computed Tomography (MSCT) Chest in Differentiation Between Chronic Obstructive Pulmonary Disease(COPD) Patients According to Their Smoking Status
- ClinicalTrials.gov ID
- NCT05475977
- Acronym / sponsor ID
- Somaia Ahmad
- Conditions
- Patient Participation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Somaia Ahmad AbdAllah AhmadUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 27 Jul 2022 (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.
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality all over the world. Smoking is considered as an important risk factor, but other risk factors are present. Around 30 % of patients with COPD are non-smokers.
Cessation of smoking in patients with COPD causes decreases the presence of micronodules and other criteria of CT chest.
In last few years, some researchers reported that cessation of smoking raise the apparent extent of emphysema. The cause is not obvious, but this paradoxical fall in lung density is thaught to be resulting from decrease in inflammation after smoking cessation.
CT chest criteria of COPD in active smokers, non-smokers and ex-smokers seem to be different.
So, comparison between CT chest Criteria of COPD in smokers, ex-smokers and non-smokers will be searched in this study to detect the role of multislice computed tomography (MSCT) chest in differentiation between COPD patients according to their smoking status.
Detailed description
Basic ethical principles of medical research; beneficence (do well), non-maleficence (do no harm), respect and distributive justice were implemented. The study will be carried out in accordance with the Declaration of Helsinki and the principles of good clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First Group | – | Diagnostic Test: MSCT chestThirty patients of COPD smokers patients. |
| Second group | – | Diagnostic Test: MSCT chestThirty patients of COPD ex-smokers patients. |
| Third group | – | Diagnostic Test: MSCT chestThirty patients of COPD non-smokers patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients either smokers, ex-smokers or non-smokers
Key inclusion criteria (2 listed)
- All patients with chronic obstructive Pulmonary Disease.
- Patients above 18 years.
Key exclusion criteria (3 listed)
- Patients with unclear smoking history.
- Patients with active pneumonia.
- Patients with acute COPD exacerbation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCT chestMulti slice Computed Tomography of the chest | Diagnostic test | First Group, Second group, Third group |
Primary outcome
Number of participants with criteria of severe COPD
Time frame: 18 months
Criteria of severe COPD include emphysematous bullae, thick bronchial walls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: Yes. COPD MSCT criteria smoking status
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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.
Somaia Ahmad AbdAllah Ahmad, M.B.B.Ch principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Participation, run by Somaia Ahmad AbdAllah Ahmad.
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 2 inclusion and 3 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 2 Aug 2022. 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 Somaia Ahmad AbdAllah Ahmad, M.B.B.Ch (01024833938, somayaahmad64@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with criteria of severe COPD (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.