UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053126 |
|---|---|
| Receipt number | R000053787 |
| Scientific Title | Comprehensive analysis in patients with ulcerative colitis and Crohn's disease treated with biological agents |
| Date of disclosure of the study information | 2023/12/16 |
| Last modified on | 2023/12/16 08:54:38 |
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Basic information
Public title
Comprehensive analysis in patients with ulcerative colitis and Crohn's disease treated with biological agents
Acronym
Comprehensive analysis in patients with UC and CD treated with biological agents
Scientific Title
Comprehensive analysis in patients with ulcerative colitis and Crohn's disease treated with biological agents
Scientific Title:Acronym
Comprehensive analysis in patients with UC and CD treated with biological agents
Region
| Japan |
Condition
Condition
Ulcerative colitis, Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Blood and stool samples are collected from UC and CD patients starting treatement with infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, tofacitinib, filgotinib, upadacitinib, risankizumab, mirikizumab, or carotegrast methyl before drug initiation, 2 weeks after drug administration, 6 weeks, 14 weeks, 6 months, and every 6 months thereafter, and upon discontinuation of the above drugs due to difficulty in continuation. Biopsy specimens are taken from patients undergoing endoscopy during the administration period.
All blood, stool, and biopsy specimens are stored for comprehensive analysis of pharmacokinetics, intestinal bacteria, and immune response. In addition, we will measure items that are worth analyzing by new findings in the future, with the aim of establishing new treatment methods for future tailor-made medicine.
Basic objectives2
Others
Basic objectives -Others
Bank of blood, stool, and biopsy specimens
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
None
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
The patients who meet the following criteria are enrolled as subjects in this study.
1, Patients who understood the explanations by documentation and oral and signed a consent form to participate in the study.
2, Patients over 18 years old, regardless of gender.
3, UC and CD Patients starting treatment with infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, tofacitinib, filgotinib, upadacitinib, risankizumab, mirikizumab, or carotegrast methyl.
Key exclusion criteria
1, Pregnant women, lactating women, or women who may be pregnant.
2, Patients who are judged by the researchers to be unsuitable for this study.
Target sample size
200
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 IBD research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
kobataku@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Shibui |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo, Japan
TEL
03-3444-6161
Homepage URL
hnori@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Kitasato Institute Hospital
Organization
Division
Category of Funding Organization
Self funding
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 Department Research Ethics Committee Secretariat
Address
5-9-1, Shirokane, Minato-ku, Tokyo, Japan
Tel
03-3444-6161
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
| 2023 | Year | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053787
