Inflammatory Biomarkers and Disease Activity in Inflammatory Bowel Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 1 trial groupGroup A: IBD Patients
Trial outcomes
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).
Time frame
Day 1Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: