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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Area Under the Receiver Operating Characteristic Curve (AUC) of the C-Reactive Protein-to-Albumin Ratio (CAR)
Time Frame: 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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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Biomarkers in IBD Activity
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