UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056095 |
|---|---|
| Receipt number | R000064098 |
| Scientific Title | Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2025/09/02 10:30:46 |
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Basic information
Public title
Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis
Acronym
Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis
Scientific Title
Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis
Scientific Title:Acronym
Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis
Region
| Japan |
Condition
Condition
Bioinformatics analysis of biomarkers for biologic selection in Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To comprehensively explore predictive biomarkers for remission/non-remission with vedolizumab (VDZ) or anti-TNF-alfa antibody using omics analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key exclusion criteria
1. Patients who declined to participate in this study.
2. Patients with missing or blank collection items required for this study.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced Treatment of Inflammatory Bowel Disease
Zip code
1088642
Address
Center for Advanced Treatment of Inflammatory Bowel Disease
TEL
0334446161
drkobataku@gmail.com
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced Treatment of Inflammatory Bowel Disease
Zip code
1088642
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
0334446161
Homepage URL
drkobataku@gmail.com
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Kitasato Institute Hospital, Research Ethics Committee
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel
0357916106
kenkyu@insti.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special remarks
Management information
Registered date
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064098
