IBD Biomarker Discovery and Validation Platform
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
6,000 Participants
are grouped into 4 trial groupsSponsors and collaborators
Source ClinicalTrials.gov