Inflammatory Biomarkers and Disease Activity in Inflammatory Bowel Disease
Evaluation of Inflammatory Biomarkers for Disease Activity in Patients With Inflammatory Bowel Disease
This study aims to evaluate the diagnostic accuracy and clinical utility of routine blood-derived inflammatory biomarker ratios in assessing disease activity among adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
Endoscopy is the standard method for evaluating mucosal inflammation in IBD, but it is invasive, costly, and inconvenient for frequent disease monitoring. Non-invasive, inexpensive laboratory markers derived from standard routine blood tests, specifically the C-reactive protein-to-albumin ratio (CAR), platelet-to-albumin ratio (PAR), neutrophil-to-lymphocyte ratio (NLR), fibrinogen-to-albumin ratio (FAR), and hemoglobin-to-CRP ratio (Hb/CRP), have shown potential in reflecting systemic and intestinal inflammation.
Participants enrolled in this cross-sectional study will undergo routine clinical disease activity evaluations and standard blood tests. For patients undergoing routine colonoscopy, endoscopic disease activity scores will also be recorded. The primary goal is to determine how accurately these blood-based ratios can differentiate active IBD from disease remission, providing a simple, cost-effective tool for regular patient monitoring.
Descripción general del estudio
Estado
Descripción detallada
Inflammatory bowel disease (IBD), encompassing Crohn's disease and ulcerative colitis, is a chronic relapsing condition requiring regular evaluation of disease activity to guide clinical decision-making and therapeutic management. While endoscopic assessment is the gold standard for mucosal evaluation, its routine application is limited by invasiveness, procedure risks, and high healthcare costs.
This cross-sectional study investigates the diagnostic accuracy and clinical utility of non-invasive, blood-based inflammatory ratios: C-reactive protein-to-albumin ratio (CAR), platelet-to-albumin ratio (PAR), neutrophil-to-lymphocyte ratio (NLR), fibrinogen-to-albumin ratio (FAR), and hemoglobin-to-C-reactive protein ratio (Hb/CRP).
Participants are recruited from the Clinical Pathology and Gastroenterology and Hepatology departments at Assiut University Hospital. Clinical disease activity is assessed using standardized clinical scores: the Mayo Clinic Score or Partial Mayo Score for ulcerative colitis, and the Crohn's Disease Activity Index (CDAI) or Harvey-Bradshaw Index (HBI) for Crohn's disease. In participants with available routine colonoscopy data within the study window, endoscopic disease activity is recorded using the Mayo Endoscopic Score (MES) or Ulcerative Colitis Endoscopic Index of Severity (UCEIS) for ulcerative colitis, and the Simple Endoscopic Score for Crohn's Disease (SES-CD) for Crohn's disease.
Venous blood samples are analyzed for complete blood count (CBC), serum albumin, C-reactive protein (CRP), and fibrinogen using automated laboratory analyzers (Advia and Atellica platforms) to calculate the corresponding inflammatory ratios and assess their discriminatory capacity.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18 years or older
- Established diagnosis of Crohn's disease or ulcerative colitis
- Availability of adequate clinical information for disease activity assessment
- For the endoscopic subgroup: colonoscopy performed as part of routine clinical care within the study window with an available endoscopic report and corresponding disease activity score
Exclusion Criteria:
- Acute systemic infection at the time of assessment
- Active malignancy
- Other active systemic inflammatory or autoimmune diseases likely to significantly influence inflammatory biomarkers
- Significant hematological disease affecting hemoglobin, leukocyte, neutrophil, lymphocyte, or platelet counts
- Severe renal or hepatic dysfunction likely to substantially influence albumin or inflammatory markers
- Recent major surgery
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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IBD Patients
Adult patients aged 18 years or older with an established diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) undergoing clinical and/or endoscopic disease activity evaluation along with routine laboratory investigations.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Area Under the Receiver Operating Characteristic Curve (AUC) of the C-Reactive Protein-to-Albumin Ratio (CAR)
Periodo de tiempo: Day 1
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AUC will be calculated using receiver operating characteristic (ROC) analysis to determine the diagnostic accuracy of the C-reactive protein-to-albumin ratio (CAR) in discriminating active disease from remission in patients with inflammatory bowel disease, defined by clinical disease activity scores (Mayo Clinic Score/Partial Mayo Score for ulcerative colitis and CDAI/HBI for Crohn's disease).
Values range from 0.5 (no discrimination) to 1.0 (perfect discrimination).
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Day 1
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Biomarkers in IBD Activity
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