Serum Anti-PCOLCE as Novel Diagnostic Biomarker in Rheumatoid Arthritis With Emphasis on Seronegative Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 主要终点
- Serum anti-PCOLCE antibody levels in rheumatoid arthritis patients versus healthy controls
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects synovial joints, leading to pain, swelling, and progressive joint damage. Early diagnosis is critical to prevent irreversible disability. However, up to 30% of RA patients are seronegative for conventional markers such as rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies, creating a diagnostic challenge. This study aims to evaluate the diagnostic performance of serum anti-procollagen C-endopeptidase enhancer (anti-PCOLCE) antibodies in RA patients, with a particular focus on seronegative cases. We will conduct a case-control study involving RA patients and age- and sex-matched healthy controls. Clinical assessments, disease activity scoring, functional disability evaluation, and laboratory testing will be performed. The findings may provide evidence for anti-PCOLCE as a novel biomarker for improved RA diagnosis.
详细描述
Rheumatoid arthritis (RA) is an inflammatory disease that primarily affects synovial joints through an autoimmune mechanism. If not treated properly, the disease can lead to bone erosion, joint deformities, and disability. Arthritis can also cause serious extra-articular disorders, including interstitial lung disease, vasculitis, and lymphoma.
The global prevalence of RA is 1%, with 44% of patients incapacitated within ten years. Increasing evidence indicates that early diagnosis and treatment of RA are crucial in preventing or delaying progression to erosive disease.
The production of antibodies to modified self-antigens is a hallmark in RA damage to synovial joints. The diagnosis of RA is based on a combination of clinical, radiographic, and serological findings. Among serological biomarkers, the most widely used are rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies. While anti-CCP antibodies are relatively specific for RA and are included in the 2010 ACR/EULAR classification criteria, they are not present in all patients. Approximately 20-30% of RA patients may test negative for both RF and anti-CCP, is termed seronegative RA (SNRA) emphasizing the need for additional, more sensitive and specific biomarkers, especially in early and seronegative RA.
Antibodies to citrullinated and carbamylated proteins are of particular interest in RA because of their high prevalence, specificity, association with erosive disease, and appearance during the preclinical phase of RA. Citrullination is a physiological posttranslational modification (PTM) best known for its role in gene regulation and skin keratinization. During this process, arginine residues are converted to citrulline by the activity of the peptidylarginine deiminase (PAD) enzymes.
Procollagen C-protease enhancer protein (PCOLCE) is a secretory glycoprotein, which plays an important role in enhancing the activity of procollagen C-Protease and promoting the reconstruction of extracellular matrix.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rheumatoid Arthritis Patients
Adult patients (≥18 years) diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.
干预措施: Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA. (Diagnostic Test)
Healthy Controls
Age- and sex-matched healthy individuals without rheumatoid arthritis or other autoimmune diseases.
干预措施: Healthy Controls
结局指标
主要结局
Serum anti-PCOLCE antibody levels in rheumatoid arthritis patients versus healthy controls
时间窗: Baseline (at the time of enrollment)
To measure serum level of anticitrullinated procollagen C endopeptidase enhancer antibody (anti-PCOLCE) in RA patients compared to healthy controls . To assess the diagnostic performance of anti PCOLCE for RA specifically seronegative RA patients.
measure serum level of anticitrullinated procollagen C endopeptidase enhancer antibody (anti-PCOLCE) in RA patients compared to healthy controls .
时间窗: At baseline (single measurement at enrollment).
To measure serum level of anticitrullinated procollagen C endopeptidase enhancer antibody (anti-PCOLCE) in RA patients compared to healthy controls . To assess the diagnostic performance of anti PCOLCE for RA specifically seronegative RA. To evaluate correlation of serum anti-PCOLCE level with disease activity and functional disability scores in RA patients .
次要结局
- Correlation between serum anti-PCOLCE antibody levels and disease activity scores in RA patients(At baseline (single assessment at enrollment).)
研究者
Mariam Rezk Lyas Ibrahim
Principal investigator
Assiut University