UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024589
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email araim-cib@umin.ac.jp

Sponsor
Institute Chiba university
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028298

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.