UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011113 |
|---|---|
| Receipt number | R000013020 |
| Scientific Title | A study on the classification of inflammatory bowel disease by the patterns of immunological profiles |
| Date of disclosure of the study information | 2013/07/04 |
| Last modified on | 2020/07/09 16:07:17 |
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Basic information
Public title
A study on the classification of inflammatory bowel disease by the patterns of immunological profiles
Acronym
Classification of inflammatory bowel disease by the patterns of immunological profiles
Scientific Title
A study on the classification of inflammatory bowel disease by the patterns of immunological profiles
Scientific Title:Acronym
Classification of inflammatory bowel disease by the patterns of immunological profiles
Region
| Japan |
Condition
Condition
Crohn's Disease, ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the array of immunological makers, such as cytokines and chemokines, will be measured in the intestinal tissue and the serum samples of patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease) and healthy volunteers to test if those diseases can be categorized into subgroups by the patterns of immunological skewing.
Basic objectives2
Others
Basic objectives -Others
1. Classification of inflammatory bowel disease by the patterns of immunological profiles.
2. The feasibility of the immunological classification of inflammatory bowel disease for the selection of proper therapeutic strategy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The immunological profiling will be determined by the measurement of cytokines, chemokines and other factors in the serum and intestinal tissue samples. The patients will be classified into subgroups by the immunological features, and the correlation of endoscopical disease activity, clinical course, and the responsiveness and/or resistance to therapy protocol with those subgroups will be analyzed.
Key secondary outcomes
The feasibility of immunological profiling for the selection of proper therapeutic strategy and prediction of the clinical course.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
5 ml of blood sample and 3 biopsy samples of the intestinal tissue will be collected from each person.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with inflammatory bowel disease and healthy volunteers.
Key exclusion criteria
[Patients]
Pregnant women are excluded.
Patients who have obvious intestinal disease and/or systemic inflammation caused by other than inflammatory bowel disease, such as advanced cancer, systemic autoimmune disease, and infections are excluded.
Patients with bleeding tendency are excluded.
[Healthy volunteers]
Pregnant women are excluded.
Persons with bleeding tendency are excluded.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Namiko Hoshi |
Organization
Kobe University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
7-5-1 Kusunoki, Chuo-Ward, Kobe, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Namiko Hoshi |
Organization
Kobe University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
TEL
078-382-5774
Homepage URL
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 07 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013020
