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

Inflammatory Bowel Diseases Clinical Trial

Official title:

Identify Specific PBMC miRNAs as Biomarkers for IBD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256538
• Other study ID #: SAHZJU2019-189
• Status: Completed
• Start date: August 15, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: June 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crohn's Disease Activity Index (CDAI)	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	2 months
Primary	Mayo Score	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	2 months