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Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis

Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis - Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056095
Enrollment
42
Registered
2024-11-30
Start date
2024-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis

Interventions

None listed

Sponsors

Kitasato University Kitasato Institute Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Samples from patients meeting the following criteria will be targeted. 1.IBD patients who have participated in the "Comprehensive analysis of ulcerative colitis and Crohn's disease patients using biologics" study (Kitasato study) from July 2019 to March 2024. Inclusion criteria of the Kitasato study is as below. 1)Patients who have provided written and verbal explanations and obtained written consent to participate in the study. 2)Patients aged 18 years or older, regardless of gender. 3)Patients starting to use infliximab, adalimumab, golimumab, ustekinumab, VDZ, tofacitinib, filgotinib, carotegrast methyl (AJM300), upadacitinib, risankizumab, mirikizumab for UC and CD (previous use of 1 or more biological agents doesn't matter) . Exclusion criteria of the Kitasato study is as below. 1)Pregnant women, lactating women, or women who may be pregnant. 2)Patients who are judged by the study director to be unsuitable as subjects for this study. 2.Those included in 1., patients diagnosed moderately to severely active UC patients at the time of initiating VDZ or anti-TNF-alfa antibody including infliximab, adalimumab, golimumab. 3.Those included in 1., patients who have serum samples before VDZ or anti-TNF-alfa antibody treatment.

Exclusion criteria

Exclusion criteria: 1. Patients who declined to participate in this study. 2. Patients with missing or blank collection items required for this study.

Design outcomes

Primary

MeasureTime frame
A multi-omics analysis* will be used to comprehensively search for predictive biomarkers related to clinical remission of the VDZ or anti-TNF-alfa antibody group, and to compare the two groups. *: Serum proteomics analysis, serum metabolomics analysis, whole blood genomics

Countries

Japan

Contacts

Public ContactTaku Kobayashi

Kitasato University Kitasato Institute Hospital Center for Advanced Treatment of Inflammatory Bowel Disease

drkobataku@gmail.com0334446161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026