- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05914532
New Biomarkers in Axial Sypondyloarthropathy; SII and SIRI
August 21, 2023 updated by: Burak Tayyip Dede, Istanbul Training and Research Hospital
In Patients With Axial Spondyloarthropathy; Evaluation of the Relationship Between the Systemic Immune Inflammation Index and the Systemic Inflammatory Response Index With Disease Activity and Function
investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA).
Study Overview
Detailed Description
The clinical characteristics and laboratory data of the patients and healthy controls participating in our study were obtained through the hospital system.
Then, the new biomarkers SIRI and SII values were calculated.
SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count.
Then, SIRI and SII values were compared between groups.
The relationship between disease activity and SIRI and SII values in the patient group was examined.
Study Type
Observational
Enrollment (Actual)
155
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Istanbul Training and Resarch Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Group 1:healthy controls working in our hospital,
Group 2: SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
Description
Inclusion Criteria:
- SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
- 51 healthy controls working in our hospital,
Exclusion Criteria:
infections, coronary artery disease, kidney and liver dysfunction, cancer diagnosis, surgery in the last three months, diabetes mellitus diagnosis, hypertension and pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group 1
healthy controls
|
Complete blood count and erythrocyte sedimentation rate and C-reactive protein values of the participants were analyzed by laboratory test.
|
|
group 2
axial spondyloarthropathy
|
Complete blood count and erythrocyte sedimentation rate and C-reactive protein values of the participants were analyzed by laboratory test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of SIRI and SII between Patient and Healthy Control
Time Frame: Baseline
|
SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation analysis of SIRI and SII with scales and laboratory findings
Time Frame: Baseline
|
SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Burak Tayyip DEDE, MD, Istanbul Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2023
Primary Completion (Actual)
July 10, 2023
Study Completion (Actual)
August 10, 2023
Study Registration Dates
First Submitted
June 10, 2023
First Submitted That Met QC Criteria
June 21, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 21, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19/08/2022, 2011-KAEK-50: 262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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