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临床试验/NCT07509463
NCT07509463已完成不适用

The CALLY Index May Reflect Systemic Inflammatory Burden Rather Than Patient-Reported Disease Activity in Ankylosing Spondylitis: A Retrospective Cross-Sectional Study

Bursa City Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Association of the CALLY index with disease activity in ankylosing spondylitis

研究概览

简要总结

This retrospective cross-sectional observational study aims to evaluate the association between the C-reactive protein-albumin-lymphocyte (CALLY) index and disease activity and functional status in patients with ankylosing spondylitis. Medical records of adult patients followed between January 1, 2022, and December 31, 2025, were reviewed. Disease activity was assessed using BASDAI and ASDAS-ESR, and functional status was evaluated using BASFI. The study investigates whether the CALLY index reflects systemic inflammatory burden beyond patient-reported disease activity

详细描述

Ankylosing spondylitis is a chronic inflammatory disease in which assessment of disease activity may require both clinical and laboratory-based measures. This retrospective cross-sectional observational study was conducted at Bursa City Hospital, Türkiye, to investigate the relationship between the C-reactive protein-albumin-lymphocyte (CALLY) index and disease-related parameters in patients with ankylosing spondylitis.

Medical records of patients aged 18 years and older who met the modified New York criteria for ankylosing spondylitis and were followed between January 1, 2022, and December 31, 2025, were retrospectively reviewed. Patients with active or chronic infection, malignancy, advanced hepatic or renal disease, nephrotic syndrome, or incomplete data were excluded.

Demographic, clinical, and laboratory data were obtained from medical records. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score based on erythrocyte sedimentation rate (ASDAS-ESR). Functional status was evaluated using the Bath Ankylosing Spondylitis Functional Index (BASFI). The CALLY index was calculated using serum C-reactive protein, albumin, and lymphocyte count values.

The primary objective of the study is to determine whether the CALLY index is associated with disease activity and functional status in ankylosing spondylitis. The study also aims to explore whether this composite biomarker reflects systemic inflammatory burden beyond subjective patient-reported measures. Ethical approval was obtained from the Bursa City Hospital Clinical Research Ethics Committee.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and older
  • Diagnosis of ankylosing spondylitis according to the modified New York criteria
  • Availability of complete clinical and laboratory data at a single assessment time point

排除标准

  • Active or chronic infection
  • Malignancy
  • Advanced hepatic or renal disease
  • Having conditions affecting serum albumin levels, such as nephrotic syndrome
  • Incomplete data

研究组 & 干预措施

Patients with ankylosing spondylitis

Patients aged 18 years and older with ankylosing spondylitis diagnosed according to the modified New York criteria, whose medical records were retrospectively reviewed between January 1, 2022, and December 31, 2025.

结局指标

主要结局

Association of the CALLY index with disease activity in ankylosing spondylitis

时间窗: At a single assessment time point

Assessment of the relationship between the C-reactive protein-albumin-lymphocyte (CALLY) index and disease activity measures, including BASDAI and ASDAS-ESR, in patients with ankylosing spondylitis.

BASDAI and ASDAS-ESR scores in relation to CALLY index

时间窗: At a single assessment time point

Assessment of the relationship between the C-reactive protein-albumin-lymphocyte (CALLY) index and disease activity measures, including BASDAI and ASDAS-ESR, in patients with ankylosing spondylitis.

次要结局

  • Association of the CALLY index with functional status (BASFI)(At a single assessment time point)
  • Association of the CALLY index with laboratory inflammatory markers (CRP, ESR, lymphocyte count, albumin)(At a single assessment time point)
  • Correlation of CALLY index with BASFI score in patients with ankylosing spondylitis(At a single assessment time point)
  • Correlation of CALLY index with CRP, ESR, lymphocyte count, and albumin levels in patients with ankylosing spondylitis(At a single assessment time point)

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Taner Dandinoğlu

Principal Investigator

Bursa City Hospital

研究点 (1)

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