Bronchiectasis AdultNCT06589492
Comparison of Serum SIRT-1 and MMP-9 Levels of Patients With Bronchiectasis and Healthy Controls
A study testing Measurement of MMP-9 and SIRT-1 levels in blood serum in people with Bronchiectasis Adult, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this a cross-sectinol study is to measure the levels of MMP-9 and SIRT-1 levels in patients with bronchiectasis and healthy controls. The aim is to compare the serum levels of these molecules between patients and controls. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Measurement of MMP-9 and SIRT-1 levels in blood serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2020to 2 Sep 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Bronchiectasis patients who were symptoms (cough, sputum production)
- Individuals whose diagnosis was confirmed by a high-resolution chest CT scan taken within the previous year
Who cannot join
- Individuals with bronchiectasis associated with cystic fibrosis and who had a worsening episode
- individuals who were pregnant or nursing
- those with low comprehension
- taken antibiotics during the previous four weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-sectional Study on the Comparison of Serum SIRT-1 and MMP-9 Levels of Patients With Bronchiectasis and Healthy Controls
The purpose of this a cross-sectinol study is to measure the levels of MMP-9 and SIRT-1 levels in patients with bronchiectasis and healthy controls. The aim is to compare the serum levels of these molecules between patients and controls.
- Is the MMP-9 level increasing or decreasing?
- Is the SIRT-1 level increasing or decreasing in patients?
- Is the disease related to age and gender? Participants will only have one 5 ml blood sample drawn when they visit the chest illness clinic. Molecule levels will be measured in this blood's serum.
Read more
The patient group participants will be scanned once with high-resolution chest CT.
Apart from this, comparisons will be made using the age and gender information of the participants.
Read the detailed description
In the overall study population of 60 subjects who applied to the Sivas Cumhuriyet University Faculty of Medicine Research and Practice Hospital Chest Diseases Clinic. The study population was selected regardless of age and gender. Participants selected bronchiectasis patients (n=30) who had symptoms (cough, sputum production) and had their diagnosis confirmed by a chest high-resolution CT scan within the previous year. The study excluded individuals with bronchiectasis not associated with cystic fibrosis and who had a worsening episode (according to the 2017 European Respiratory Society expert consensus criteria) (16) or had taken antibiotics during the previous four weeks. The study enrolled healthy controls (n=30) through advertisements who had acceptable chest X-ray and spirometry results and no lower airway symptoms or serious systemic disorders. The study eliminated individuals who were pregnant or nursing, as well as those with low comprehension. SIRT-1 and MMP-9 levels in the serum of the study group were determined by the ELISA method.
- Conditions
- Bronchiectasis Adult
- Being tested
- Measurement of MMP-9 and SIRT-1 levels in blood serum
- Keywords
- Bronchiectasis, MMP-9, SIRT-1
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of MMP-9 and SIRT-1 levels in blood serumDiagnostic test
Measurement of MMP-9 and SIRT-1 levels in blood serum, Collection of 5 ml Blood samples
| Study group | Role | What they receive |
|---|---|---|
| CT scan | No intervention | Chest high-resolution CT scan will be performed for diagnosis of patients. |
| Age, gender | No intervention | Age and gender information of patients will be obtained for comparison. |
| Measurement of MMP-9 and SIRT-1 levels in blood serum | Experimental | It involves taking 5ml of blood from participants to measure mmp-9 and SIRT-1 levels in blood serum. Receives: Diagnostic Test: Measurement of MMP-9 and SIRT-1 levels in blood serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-9 and SIRT-1 levels (ng/mL) mesurment in the blood serum to compare between patient and control.
MMP-9 and SIRT-1 levels mesured in the blood serum. The most common side effect when blood is taken from the patient is slight bruising and swelling in the arm due to needle sticking. There will be no other serious side effects.
Measured: not measured in time frame. general (1. day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Nov 2020
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Ulger Ozbek, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589492
- Sponsor's protocol ID
- Biochemistry AD
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: can be published after being converted into a working article
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study on the Comparison of Serum SIRT-1 and MMP-9 Levels of Patients With Bronchiectasis and Healthy Controls
- ClinicalTrials.gov ID
- NCT06589492
- Acronym / sponsor ID
- Biochemistry AD
- Conditions
- Bronchiectasis Adult
- Keywords
- Bronchiectasis, MMP-9, SIRT-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 19 Sep 2024 (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.
The purpose of this a cross-sectinol study is to measure the levels of MMP-9 and SIRT-1 levels in patients with bronchiectasis and healthy controls. The aim is to compare the serum levels of these molecules between patients and controls.
- Is the MMP-9 level increasing or decreasing?
- Is the SIRT-1 level increasing or decreasing in patients?
- Is the disease related to age and gender? Participants will only have one 5 ml blood sample drawn when they visit the chest illness clinic. Molecule levels will be measured in this blood's serum.
The patient group participants will be scanned once with high-resolution chest CT.
Apart from this, comparisons will be made using the age and gender information of the participants.
Detailed description
In the overall study population of 60 subjects who applied to the Sivas Cumhuriyet University Faculty of Medicine Research and Practice Hospital Chest Diseases Clinic. The study population was selected regardless of age and gender. Participants selected bronchiectasis patients (n=30) who had symptoms (cough, sputum production) and had their diagnosis confirmed by a chest high-resolution CT scan within the previous year. The study excluded individuals with bronchiectasis not associated with cystic fibrosis and who had a worsening episode (according to the 2017 European Respiratory Society expert consensus criteria) (16) or had taken antibiotics during the previous four weeks. The study enrolled healthy controls (n=30) through advertisements who had acceptable chest X-ray and spirometry results and no lower airway symptoms or serious systemic disorders. The study eliminated individuals who were pregnant or nursing, as well as those with low comprehension. SIRT-1 and MMP-9 levels in the serum of the study group were determined by the ELISA method.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT scan | No intervention | –Chest high-resolution CT scan will be performed for diagnosis of patients. |
| Age, gender | No intervention | –Age and gender information of patients will be obtained for comparison. |
| Measurement of MMP-9 and SIRT-1 levels in blood serum | Experimental | Diagnostic Test: Measurement of MMP-9 and SIRT-1 levels in blood serumIt involves taking 5ml of blood from participants to measure mmp-9 and SIRT-1 levels in blood serum. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Bronchiectasis patients who were symptoms (cough, sputum production)
- Individuals whose diagnosis was confirmed by a high-resolution chest CT scan taken within the previous year
Key exclusion criteria (4 listed)
- Individuals with bronchiectasis associated with cystic fibrosis and who had a worsening episode
- individuals who were pregnant or nursing
- those with low comprehension
- taken antibiotics during the previous four weeks
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 |
|---|---|---|
| Measurement of MMP-9 and SIRT-1 levels in blood serumMeasurement of MMP-9 and SIRT-1 levels in blood serum, Collection of 5 ml Blood samples | Diagnostic test | Measurement of MMP-9 and SIRT-1 levels in blood serum |
Primary outcome
MMP-9 and SIRT-1 levels (ng/mL) mesurment in the blood serum to compare between patient and control.
Time frame: not measured in time frame. general (1. day)
MMP-9 and SIRT-1 levels mesured in the blood serum. The most common side effect when blood is taken from the patient is slight bruising and swelling in the arm due to needle sticking. There will be no other serious side effects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. can be published after being converted into a working article
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of MMP-9 and SIRT-1 levels in blood serum in people with Bronchiectasis Adult, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMP-9 and SIRT-1 levels (ng/mL) mesurment in the blood serum to compare between patient and control. (time frame: not measured in time frame. general (1. day)). 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 19 Sep 2024.