UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051370 |
|---|---|
| Receipt number | R000058611 |
| Scientific Title | Cytokine profiles and identification of novel biomarkers for treatment optimization of ulcerative colitis |
| Date of disclosure of the study information | 2023/06/18 |
| Last modified on | 2023/06/18 12:09:50 |
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Basic information
Public title
Cytokine profiles and identification of novel biomarkers for treatment optimization of ulcerative colitis
Acronym
Cytokine profile of ulcerative colitis
Scientific Title
Cytokine profiles and identification of novel biomarkers for treatment optimization of ulcerative colitis
Scientific Title:Acronym
Cytokine profile of ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Ulcerative colitis (UC) is one of the representative inflammatory bowel diseases of unknown origins, the mechanism of which is considered imbalance of immune function to dysbiosis of intestinal microbiota from Western fatty diet and psychological factors. Although it is an intractable disease designated by the Ministry of Health, Labour and Welfare in Japan, the development of various therapeutic agents in recent years has made it possible to induce and maintain remission. However, we often experience patients in whom one drug is ineffective but another drug is effective. Therefore, it is important to select the appropriate therapeutic option from the beginning. Regarding biologic agents, secondary failure develops due to anti-drug antibodies. In the present study, we take colonoscopic biopsies, blood, and stool samples from patients with UC before and after treatment, and analyze changes in various cytokines of these samples, and anti-drug antibodies and trough levels of biologic agents to determine which drug would be predicted to be more effective to each patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Identification of mucosal and blood cytokines and biomarkers associated with therapeutic outcome
Key secondary outcomes
1. Pathological finding of colonoscopic biopsies associated with therapeutic outcome
2. Fecal microbiota associated with therapeutic outcome
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis
Patients who provides the written informed consent
Key exclusion criteria
Patients who are considered inappropriate to undergo colonoscopy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University School of Medicine
Division name
Department of Advanced Endoscopy
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192
TEL
0562939240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University School of Medicine
Division name
Department of Advanced Endoscopy
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192
TEL
0562939240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Ohmiya
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University School of Medicine IRB
Address
-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562932860
research@fujita-hu.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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2028 | Year | 05 | Month | 30 | Day |
Other
Other related information
Nothing
Management information
Registered date
| 2023 | Year | 06 | Month | 18 | Day |
Last modified on
| 2023 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058611
