Peking University First Hospital
Beijing, China
Location status: Recruiting
NCT Number: NCT07181525
Inflammatory bowel disease (IBD) is a group of chronic progressive gastrointestinal diseases that can recur throughout life and for which there is no cure. Biologics, the first line of treatment, are not only expensive, but also 30-50% of patients lack response to this type of drug therapy. However, there is a lack of reliable methods to predict the clinical efficacy of biologics. The aim of this study is to construct a reliable model to predict patients' response to biologics therapy by comprehensively analysing patients' clinical characteristics, biomarkers and other information to guide individualized therapy. In this study, we will collect clinical data from IBD patients at Peking University First Hospital, including but not limited to patients' baseline characteristics, biomarker levels, and efficacy responses, etc. We will establish a complete patient dataset using a cohort study, train and test the dataset by applying correlation analysis, multiple regression analysis, and machine learning algorithms (e.g. neural networks etc), establish and compare the prediction effects of different models The optimal model is selected for encapsulation and developed into a user-friendly clinical prediction tool. This study will contribute to clinical decision making for IBD patients, improve treatment outcomes, and reduce unnecessary healthcare costs.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Beijing, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Different kinds of biologics used to treat inflammatory bowel disease (including anti-cytokine antibodies)
Different kinds of biologics used to treat inflammatory bowel disease (including anti-integrin antibodies)
Time frame: up to 8 weeks
For UC patients, the modified Mayo scoring system was used to evaluate the disease activity of UC patients, and the items involved in the score included the number of bowel movements, blood in the stool, endoscopic performance and physician's overall evaluation, and the sum of the scores was <2 points without a single sub->1 is considered to be in remission, ≥ 3 points or a single sub-item> 2 points are considered active period; For CD patients, the severity of disease activity is assessed using Best's Crohn's disease activity index (CDAI), including the number of loose stools, abdominal pain, general conditions, extraintestinal manifestations and complications, opioid antidiarrheal use, abdominal masses, decreased hematocrit, and weight loss≥<.
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Peking University First Hospital
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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