IBD Biomarker Discovery and Validation Platform
Observational · No treatment assigned · 2 sites · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD), Ulcerative Colitis (UC) and Inflammatory Bowel Diseases (IBD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 14 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Eligibility Criteria:
- General inclusion criteria for all participants:
- Age 14 years or older.
Plus 18 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 6000 participants are expected to take part.
- Start date: 2022-01-01.
- Main results expected around 2028-12-31 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in China.
Main thing being measured
- Diagnostic Performance of Candidate Biomarkers or Combined Biomarker Models for Endoscopic Disease Activity (At paired biospecimen and endoscopy assessments, with biospecimen collection within 30 days before or after endoscopy;…)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Diseases (IBD) |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 6000 (estimated) |
| Start date | 2022-01-01 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2026-07-07 |
| Last updated | 2026-07-07 |
| Official title | Biomarker Discovery, Validation, and Multi-Omics Profiling for Disease Activity Assessment, Treatment Monitoring, and Risk Stratification in Inflammatory Bowel Disease: A Multicenter Prospective Biospecimen-Based Observational Cohort Study |
| ClinicalTrials.gov ID | NCT07686406 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong | China | Recruiting |
| The Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong | China | Completed |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.