Inflammatory Biomarkers and Disease Activity in Inflammatory Bowel Disease

Sponsor
Assiut University
Study ID
NCT07788131
Status
Not Yet Recruiting

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Conditions

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 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.

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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