NCT07686406 IBD Biomarker Discovery and Validation Platform

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 6,000 participants in total. It began in 2022-01-01 with a primary completion date of 2028-12-31.

Brief Summary

The goal of this observational study is to establish a multicenter prospective clinical and biospecimen platform for biomarker discovery and validation in inflammatory bowel disease, including Crohn's disease and ulcerative colitis. Researchers want to learn whether candidate biomarkers or combined biomarker models can help assess intestinal inflammation, monitor response to routine clinical treatment, predict treatment outcomes, and identify participants who may be at higher risk of disease progression. The study may enroll participants with inflammatory bowel disease, unaffected first-degree relatives of participants with inflammatory bowel disease, unrelated healthy controls, and non-IBD disease controls when appropriate. Clinical information and biological samples, including blood, stool, and intestinal tissue, may be collected. Biomarkers measured in blood, stool, intestinal tissue, genetic data, immune profiles, microbiome data, and other multi-omics data may be evaluated. The main questions this study aims to answer are: Can candidate biomarkers or combined biomarker models identify endoscopic disease activity when compared with endoscopic assessment? Can these biomarkers monitor or predict clinical response, clinical remission, endoscopic response, endoscopic remission, imaging response, or biomarker response during routine clinical care? Can these biomarkers help predict treatment failure, disease progression, hospitalization, surgery, treatment escalation, or complex Crohn's disease phenotypes? Participants will not be assigned to any treatment by the study. All treatments and clinical management decisions will be chosen by treating physicians as part of routine medical care.

Eligibility Criteria

Eligibility Criteria: Inclusion Criteria: 1. General inclusion criteria for all participants: * Age 14 years or older. * Able to provide written informed consent; for minors, consent from a legal guardian and assent from the participant will be obtained according to local ethics requirements. * Willing to provide clinical information and/or biospecimens, which may include blood, stool, intestinal tissue, or other available biological samples. * Able to participate in study-related data and sample collection according to the study protocol. 2. Participants with inflammatory bowel disease: * Diagnosed with inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or IBD-unclassified when applicable, according to accepted national or international diagnostic criteria. * May be newly diagnosed, previously diagnosed, under routine follow-up, or receiving routine clinical treatment. * Clinical data, treatment exposure information, laboratory results, endoscopic findings, histologic findings, imaging findings, biospecimens, and follow-up outcomes may be available or collected. 3. Unaffected first-degree relatives of participants with inflammatory bowel disease: * Biological first-degree relatives of participants with inflammatory bowel disease, including parents, siblings, or offspring. * No prior diagnosis of inflammatory bowel disease at enrollment. * Willing to provide clinical information and/or biospecimens for family-based genetic, environmental, immune, microbiome, and multi-omics analyses. 4. Unrelated healthy controls: * Individuals without a diagnosis of inflammatory bowel disease. * No first-degree biological relationship to enrolled participants with inflammatory bowel disease. * No known active gastrointestinal inflammatory disease at enrollment. 5. Non-IBD disease controls: * Individuals with gastrointestinal symptoms or other non-IBD conditions who undergo clinical evaluation but are not diagnosed with inflammatory bowel disease. * Clinical information and/or biospecimens may be collected as disease controls when appropriate. Exclusion Criteria: * Refusal or inability to provide informed consent or required assent when applicable. * Active severe infection or chronic infectious disease that may substantially affect biomarker interpretation, including active tuberculosis, active hepatitis B or C, HIV infection, or other clinically significant active infection. * Pregnancy or lactation at the time of enrollment. * Severe mental illness, cognitive impairment, or other condition that prevents cooperation with study procedures. * Known primary extraintestinal autoimmune disease or systemic inflammatory disease that is considered the main disease and may substantially confound biomarker interpretation. * Current or recent participation in another interventional clinical trial that may substantially affect the study biomarkers or outcome assessments, as judged by the investigator. * History of malignant tumor or other severe comorbidity that may substantially affect study participation or biomarker interpretation, as judged by the investigator. * Inadequate biospecimen quality, missing key clinical information, or inability to complete essential study assessments for the relevant analysis.

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