Identify Specific Peripheral Blood Mononuclear Cell (PBMC) MiRNA as Biomarkers for Inflammatory Bowel Disease (IBD)

Completed

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT04256538
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

To find high sensitivity and specificity biomarkers to better diagnose and monitor progression of inflammatory bowel disease (IBD). In this study, we try to find miRNAs that can used to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and healthy controls. And we further validate these miRNAs in a larger population to assess their function as biomarkers.

Detailed Description

Incidence of inflammatory bowel disease (IBD) has been rising in the past decades. However, diagnosis and differential diagnosis of IBD still lack gold standard. To diagnose IBD, physicians need to combine clinical manifestation, lab results, image examination, endoscopy examination and pathology. After diagnosis, patients still need to monitor their disease progression. The most accurate way is to do endoscopy examination, however, endoscopy examination is an invasive, expensive and uncomfortable procedure. At present, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and fecal calprotectin are used as main noninvasive biomarkers to monitor progression routinely. But their specificities are still unsatisfactory. So, it's urgent to find high sensitivity and specificity biomarkers to better diagnose and monitor progression of IBD. In this study, we try to find miRNAs that can used to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and healthy controls. And we further validate these miRNAs in a larger population to assess their function as biomarkers.

Study Timeline

• Study Start: 2019-08-15
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Primary Completion: 2020-05-31
• Study Completion: 2020-06-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Diagnosed as Crohn's disease (CD) or ulcerative colitis (UC) according to World Health Organization (WHO) criteria
• Vital signs are stable

Exclusion Criteria

• Refuse to sign consent
• Refuse to do examination to assess their disease progression
• CD patients only upper gastrointestinal tract (GI) is involved (L4)
• Had colectomy or in artificial opening status
• Have other autoimmune comorbidity
• Had severe infection within a week
• Had surgery within a month
• Have malignant tumor
• Pregnancy or lactation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index (CDAI)	2 months	Crohn's Disease Activity Index (CDAI) has been developed to assess whether or not the pathology of Crohn's disease is progressing.; The index is the sum of 8 components, to each of which is assigned a specific weight. \<150 suggests remission, 151-219 suggests mild activity, 220-450 suggests moderate activity, \>450 suggests severe activity
Mayo Score	2 months	The full Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation and Physician's global assessment.; Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity).; 0-2 suggests remission, 3-5 suggests mild activity,6-10 suggests moderate activity, \>10 suggests severe activity

Trial Locations

Locations (1)

2nd Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China