UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054449 |
|---|---|
| Receipt number | R000062164 |
| Scientific Title | Clinical Trial on the Impact of Biologic Agents on Crohn's Disease Strictures |
| Date of disclosure of the study information | 2024/05/25 |
| Last modified on | 2024/05/21 15:43:29 |
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Basic information
Public title
Cellular Dynamics Associated with Crohn's Disease Strictures: An Examination of the Impact of Biologic Agents
Acronym
Crohn's Disease Stricture Treatment Trial (CDSTT)
Scientific Title
Clinical Trial on the Impact of Biologic Agents on Crohn's Disease Strictures
Scientific Title:Acronym
Biologic Impact on Crohn's Stricture Trial (BICST)
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate how existing medications for Crohn's disease affect cells involved in fibrosis and whether their effects vary by medication. Specifically, it involves collecting biopsy specimens and brush cytology samples from the same sites during endoscopic examinations before and after treatment with biologic agents. The study will closely examine how cellular dynamics and mucosa-associated microbiota change locally as a result of the treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene Expression Patterns of Fibroblasts in Strictures
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
Patients with Crohn's disease who are either outpatient or inpatient at our institution.
Patients aged 18 to under 80 years at the time of enrollment.
Patients who have provided written informed consent to participate in the study.
Key exclusion criteria
Patients with any of the following history or complications:
Intestinal tuberculosis
Nonspecific multiple small bowel ulceration
NSAIDs-induced ulcer
Cases where the treatment medication has been changed within one year prior to tissue collection (e.g., from Ustekinumab to Infliximab)
Cases using steroids within one year prior to tissue collection
Any other patients whom the principal investigator or attending physician deems unsuitable for safe participation in the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | YUKI |
| Middle name | |
| Last name | HIRATA |
Organization
Osaka Medical and Pharmaceutical University
Division name
Second department of Internal Medicine
Zip code
5690801
Address
2-7, Daigaku-machi, Takatsuki City, Osaka
TEL
0726831221
yuki.hirata.ln@ompu.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | HIRATA |
Organization
Osaka Medical and Pharmaceutical University
Division name
Second department of Internal Medicine
Zip code
5690801
Address
2-7, Daigaku-machi, Takatsuki City, Osaka
TEL
0726831221
Homepage URL
yuki.hirata.ln@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University
Address
2-7, Daigaku-machi, Takatsuki City, Osaka
Tel
0726831221
yuki.hirata.ln@ompu.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 | 05 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objective of this study is to elucidate the changes induced by local cellular and biological agent treatments in intestinal strictures caused by Crohn's disease. To achieve this, we will isolate cells from the stricture sites and sort epithelial cells, fibroblasts, macrophages, and other cell types to analyze changes in gene expression. Additionally, we will examine alterations in the gut microbiota through scrape biopsy samples.
Management information
Registered date
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062164
