Model to predict which biologic works best for inflammatory bowel disease patients
Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease
This project will try to build a model that predicts which IBD patients are likely to respond to different biologic medicines using their clinical and lab data.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07181525 on ClinicalTrials.gov |
What this trial studies
Researchers will collect clinical characteristics, biomarker results, treatment details, and outcome data from a cohort of IBD patients treated at Peking University First Hospital. The focus is on patients receiving anti-cytokine or anti-integrin biologics during active disease. The assembled dataset will be analyzed with correlation analysis, multiple regression, and machine-learning methods to train and test predictive models of treatment response. The goal is to validate a tool that can help clinicians choose the most appropriate biologic for individual patients.
Who should consider this trial
Good fit: Ideal candidates are IBD patients treated at Peking University First Hospital who are in an active disease phase, receive biologic therapy, and have baseline and follow-up clinical and biomarker data available.
Not a fit: Patients who have never received biologics, are in sustained remission, have other autoimmune diseases requiring biologics, or have severe complications such as malignancy or gastrointestinal perforation are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the model could help doctors choose the biologic most likely to work for each patient, reducing ineffective treatment, side effects, and cost.
How similar studies have performed: Previous studies using biomarkers and machine-learning to predict biologic response in IBD have shown some promising but inconsistent results and generally lack broad external validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are clinically diagnosed with IBD in our hospital * Disease activity is in the active stage * Receiving biologics after diagnosis * Have relevant data on clinical evaluation results after receiving biologics treatment Exclusion Criteria: * IBD patients who have not been treated with biologics after diagnosis * Patients diagnosed with IBD but also with other autoimmune diseases that require biologics to be treated * Patients with hematological diseases and other systemic chronic inflammatory diseases involving the intestine Patients with serious complications including malignant tumors and gastrointestinal perforation.
Where this trial is running
Beijing
- Peking University First Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Raphael Hong
- Email: doctoraphael@126.com
- Phone: +86 (010)83575675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.