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

Status

Completed

Intervention / Treatment

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

      • Istanbul, Turkey
        • Istanbul Training and Resarch Hospital

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

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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