NCT06589492

Brief 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.

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.8 years

First QC Date

September 4, 2024

Last Update Submit

September 9, 2024

Conditions

Keywords

BronchiectasisMMP-9SIRT-1

Outcome Measures

Primary Outcomes (1)

  • 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.

    not measured in time frame. general (1. day)

Study Arms (3)

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.

Diagnostic Test: Measurement of MMP-9 and SIRT-1 levels in blood serum

Interventions

Measurement of MMP-9 and SIRT-1 levels in blood serum, Collection of 5 ml Blood samples

Measurement of MMP-9 and SIRT-1 levels in blood serum

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumhuriyet University

Sivas, Si̇vas Centre, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

November 2, 2020

Primary Completion

September 2, 2022

Study Completion

September 2, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

can be published after being converted into a working article

Locations