Biomarker Discovery and Validation Platform for Inflammatory Bowel Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study will collect clinical data and biospecimens from people with inflammatory bowel disease, their unaffected relatives, and appropriate control groups to build a platform for biomarker discovery and validation. The study will generate and analyze multi-omics data (blood, stool, tissue, genetics, immune profiles, microbiome) alongside endoscopic and histologic findings to explore relationships with disease activity and treatment outcomes. It does not involve any interventional treatment; management decisions remain with the treating clinicians. Endoscopic assessment serves as the primary reference standard for evaluating biomarker performance in reflecting inflammation and disease progression risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Completed

Study contacts

• Study coordinator: Wei Wang, MD & PhD
• Email: wangw239@mail.sysu.edu.cn
• Phone: 18702046420

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• CEDUR — German inflammatory bowel disease registry

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.