UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024589 |
|---|---|
| Receipt number | R000028298 |
| Scientific Title | The investigation of comprehensive genetic mutation in patients with ulcerative colitis. |
| Date of disclosure of the study information | 2016/10/27 |
| Last modified on | 2016/10/27 14:09:00 |
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Basic information
Public title
The investigation of comprehensive genetic mutation in patients with ulcerative colitis.
Acronym
The investigation of comprehensive genetic mutation in ulcerative colitis.
Scientific Title
The investigation of comprehensive genetic mutation in patients with ulcerative colitis.
Scientific Title:Acronym
The investigation of comprehensive genetic mutation in ulcerative colitis.
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the comprehensive genetic mutation of inflammatory mucosa, noarmal mucosa, plasma, buffy coat.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The genetic mutaion of buffy coat, plasma, inflammaty mucosa, normal mucosa.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Gene |
Interventions/Control_1
Pick up the inflammaoty mucosa, normal mucosa, plasma, Buffy coat.And we then analyze genetic mutation.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who contract ulceratie colitis for more than 10 years. And patients who cotract ulcerative colitis for less than 1 year.
Key exclusion criteria
patients who are less than 18 years.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba university
Division name
Department of gastroenterology
Zip code
Address
1 8 1 Inohana Cyuo ward Chiba city
TEL
043-222-7171
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba university
Division name
gastroenterology and neohrology
Zip code
Address
1 8 1 Inohana Cyuo ward Chiba city
TEL
043-222-7171
Homepage URL
araim-cib@umin.ac.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Chiba university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2016 | Year | 10 | Month | 27 | 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
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028298
