Inflammatory Biomarkers and Disease Activity in Inflammatory Bowel Disease
- Sponsor
- Assiut University
- Study ID
- NCT07788131
- Status
- Not Yet Recruiting
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Conditions
- Crohn Disease
- Inflammatory Bowel Diseases
- Ulcerative Colitis (UC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- First listed
- Aug 26, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Sep 30, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 120 participants (estimated)
Arms
- Arm: IBD PatientsAdult 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.
Primary Outcome Measure
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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