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Serum Anti-PCOLCE as Novel Diagnostic Biomarker in Rheumatoid Arthritis With Emphasis on Seronegative Patients.

NCT07129837 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2025-08-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Clinical evaluation, disease activity and disability scoring, and laboratory testing including RF, anti-CCP, and serum anti-PCOLCE antibody measurement by ELISA.

For rheumatoid arthritis (RA) patients: participants will undergo comprehensive clinical evaluation including demographic data, detailed history, musculoskeletal and systemic examination, assessment of disease activity using DAS-28 score, functional disability evaluation by modified Health Assessment Questionnaire (mHAQ), and laboratory investigations including CBC, ESR, CRP, rheumatoid factor (RF), anti-cyclic citrullinated peptide (anti-CCP) antibodies, and serum anti-procollagen C-endopeptidase enhancer (anti-PCOLCE) antibodies measured by ELISA. For healthy controls: participants will undergo comprehensive clinical evaluation including demographic data, detailed history, musculoskeletal and systemic examination, and laboratory testing limited to serum anti-PCOLCE antibodies measured by ELISA.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-03-31
Completion
2027-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07129837 on ClinicalTrials.gov