Inflammatory Biomarkers and Disease Activity in Inflammatory Bowel Disease

NCT07788131 | Not Yet Recruiting

• 1 other identifier: Biomarkers in IBD Activity
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis (UC)

Keywords

C-reactive protein-to-albumin ratio; Platelet-to-albumin ratio; Neutrophil-to-lymphocyte ratio; Fibrinogen-to-albumin ratio; Hemoglobin-to-CRP ratio; Disease Activity; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Area Under the Receiver Operating Characteristic Curve (AUC) of the C-Reactive Protein-to-Albumin Ratio (CAR)

  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).

  Day 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with an established diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) presenting to the Department of Gastroenterology and Hepatology and the Department of Clinical Pathology at Assiut University Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Clinical Pathology

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08