IBD Biomarker Discovery and Validation Platform

NCT07686406 | Recruiting

• 1 other identifier: 2023ZSLYEC-025
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Crohn Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Diseases (IBD)

Keywords

Biomarker discovery; Biomarker validation; Prospective observational cohort Disease activity; Endoscopic activity; Histologic activity; Treatment monitoring; Treatment response; Risk stratification; Disease progression; Leucine-rich alpha-2 glycoprotein; Fecal calprotectin; Oncostatin M; TL1A; TNFSF15; Multi-omics

Outcome Measures

Primary Outcomes (2)

• Diagnostic Performance of Candidate Biomarkers or Combined Biomarker Models for Endoscopic Disease Activity

  Diagnostic performance of pre-specified and newly identified candidate biomarkers or combined biomarker models for identifying endoscopic disease activity in inflammatory bowel disease. Endoscopic assessments will serve as the primary reference standard. Reference measures may include SES-CD, standardized small-bowel endoscopic assessments, capsule endoscopy scores, Mayo endoscopic score, UCEIS, or other accepted endoscopic assessments when applicable. Performance measures will include AUC, sensitivity, specificity, positive predictive value, negative predictive value, and biomarker cut-off values. Cut-off values will be explored in discovery datasets and evaluated in internal and external validation cohorts.

  At paired biospecimen and endoscopy assessments, with biospecimen collection within 30 days before or after endoscopy; assessed from enrollment through 52 weeks per participant

• Predictive Performance of Candidate Biomarkers or Combined Biomarker Models for Treatment Response

  Predictive performance of baseline candidate biomarkers, longitudinal biomarker changes, or combined biomarker models for response to routine clinical treatment will be evaluated. Treatment response outcomes may include clinical response, clinical remission, endoscopic response, endoscopic remission, inflammatory marker response, imaging response, treatment escalation, treatment failure, hospitalization, surgery, or relapse when available. Treatments are not assigned by the study and are recorded only as routine-care clinical exposures.

  From treatment baseline to induction assessment at approximately 12 to 16 weeks; maintenance assessment up to 52 weeks when available

Secondary Outcomes (10)

• Diagnostic Performance of Candidate Biomarkers or Combined Biomarker Models for Histologic Disease Activity and Remission

  At paired biospecimen and histologic assessments, with biospecimen collection within 30 days before or after tissue sampling; assessed from enrollment through 52 weeks per participant when available

• Concordance and Predictive Performance of Candidate Biomarkers or Combined Models for Clinical Remission Rate

  At treatment baseline and routine-care follow-up assessments, including induction assessment at approximately 12 to 16 weeks and maintenance assessment up to 52 weeks per participant when available

• Concordance and Predictive Performance of Candidate Biomarkers or Combined Models for Clinical Response Rate

  At treatment baseline and routine-care follow-up assessments, including induction assessment at approximately 12 to 16 weeks and maintenance assessment up to 52 weeks per participant when available

• Concordance Between Candidate Biomarkers or Combined Models and Fecal Calprotectin for Intestinal Inflammatory Activity

  At paired biospecimen and fecal calprotectin assessments at baseline, induction assessment at approximately 12 to 16 weeks, and maintenance assessment up to 52 weeks per participant when available

• Concordance Between Candidate Biomarkers or Combined Models and C-Reactive Protein for Systemic Inflammatory Activity

  At paired biospecimen and C-reactive protein assessments at baseline, induction assessment at approximately 12 to 16 weeks, and maintenance assessment up to 52 weeks per participant when available

Other Outcomes (4)

• Discovery of Multi-Omics-Derived Candidate Biomarkers

  From baseline biospecimen collection through available follow-up, up to 52 weeks per participant when available

• Association of Genetic and Pharmacogenetic Markers With Treatment Outcomes

  From treatment baseline through available follow-up, up to 52 weeks per participant when available

• Family-Based Differences in Biomarker Profiles

  At baseline or first available biospecimen collection

Study Arms (4)

Participants With Inflammatory Bowel Disease

Participants diagnosed with inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or IBD-unclassified when applicable. Clinical data, treatment exposure information, endoscopic and histologic assessments, laboratory results, imaging findings, biospecimens, and follow-up outcomes may be collected.

Unaffected First-Degree Relatives of Participants With IBD

Biological first-degree relatives of participants with inflammatory bowel disease, including parents, siblings, or offspring, who have not been diagnosed with inflammatory bowel disease. Clinical information and biospecimens may be collected to support family-based analyses of genetic susceptibility, shared environmental exposure, immune profiles, microbiome features, and multi-omics biomarkers.

Unrelated Healthy Controls

Healthy control participants without inflammatory bowel disease and without a first-degree biological relationship to enrolled participants with inflammatory bowel disease. Clinical information and biospecimens may be collected as reference controls.

Non-IBD Disease Controls

Participants with gastrointestinal symptoms or other non-IBD conditions who undergo clinical evaluation but are not diagnosed with inflammatory bowel disease. Clinical information and biospecimens may be collected as disease controls when appropriate.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This multicenter prospective observational cohort will enroll approximately 6,000 participants aged 14 years or older. The study population may include participants with inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or IBD-unclassified; unaffected first-degree relatives of participants with inflammatory bowel disease; unrelated healthy controls; and non-IBD disease controls. Clinical information, treatment exposure data, follow-up outcomes, and biospecimens may be collected to support biomarker discovery, validation, multi-omics research, treatment monitoring, and risk stratification. Participants with severe active infection, pregnancy or lactation, severe mental illness, or major confounding systemic inflammatory or autoimmune diseases may be excluded.

You may qualify if:

• 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.
• 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.
• 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.
• Unrelated healthy controls:
• Individuals without a diagnosis of inflammatory bowel disease.
• No first-degree biological relationship to enrolled participants with inflammatory bowel disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (2)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

COMPLETED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, serum, plasma, stool samples, intestinal mucosal tissue or biopsy specimens, and extracted DNA, RNA, protein, or other biospecimen derivatives may be retained. These samples will be used for biomarker, genetic, immune, microbiome, transcriptomic, proteomic, metabolomic, tissue-based, and other multi-omics analyses related to inflammatory bowel disease.

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases; Disease Progression

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wei Wang, MD & PhD

CONTACT

18702046420; wangw239@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: July 7, 2026
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)