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

NCT04256538 | Completed

• 1 other identifier: SAHZJU2019-189
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Crohn's Disease Group

Patients are diagnosed as Crohn's disease and have no history of colectomy.

Ulcerative Colitis Group

Patients are diagnosed as ulcerative colitis and have no history of colectomy.

Healthy Control Group

Individuals that have no past medical history.

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 14-75 years old, diagnosed as CD or UC according to WHO criteria, are recruited at specialist IBD clinic. They are excluded if upper GI is the only involved part, had colectomy or in artificial opening status or have other autoimmune comorbidity.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 5, 2020
• Study Start: August 15, 2019
• Primary Completion: May 31, 2020
• Study Completion: June 30, 2020
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

CN (1)