2nd Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
NCT Number: NCT04256538
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.
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Notify Me14 year–75 year
All sexes
Observational
Hangzhou, Zhejiang, 310009, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Identify Specific PBMC miRNAs as Biomarkers for IBD
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