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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035011
Receipt No. R000039523
Scientific Title Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Date of disclosure of the study information 2018/11/26
Last modified on 2018/11/26

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Basic information
Public title Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Acronym Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Scientific Title Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Scientific Title:Acronym Predictive factor analysis for treatment of Ulcerative Colitis with Tofacitinib
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Oncostatin M and phosphorylated STAT in colonic biopsy tissue before and after treatment for patients treated with tofacitinib for ulcerative colitis were measured by ELISA and it could be a biomarker for prognostic prediction Will be examined. In addition, RNA is collected from colon biopsy tissue before and after treatment, comprehensive analysis of microRNA is performed, and a biomarker for new prognostic prediction is searched.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between the amount of phosphorylated STAT change in colonic mucosa before treatment and 4 weeks after treatment and the change in disease activity before treatment and 16 weeks after treatment
Key secondary outcomes 1.Correlation between oncostatin M change in colonic mucosa before treatment and 4 weeks after treatment and disease activity change before treatment and after 16 weeks of treatment
2.Correlations between changes in peripheral blood oncostatin M, IL-6, TNF-alpha, IFN-gamma before and 4 weeks before treatment and disease activity change before and after treatment 16
3.In the comprehensive analysis of colonic mucosal microRNA before treatment and after 4 weeks, it is an item to be collected exploratory and there is a possibility of setting additional items due to future research and clinical course.

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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Target disease: refractory ulcerative colitis of moderate or more
2. Age: patients over 20 years old and under 75 years old
3. Gender: No prejudice
4. After receiving sufficient explanation for participation in the research, after sufficient understanding, freedom of the subject himself / herself
Patient who obtained document consent by intention.
Key exclusion criteria 1. Patients with severe liver and kidney dysfunction
2. Patients with a history of drug hypersensitivity such as allergy to the ingredients of this drug
3. Pregnant women and patients who may be pregnant or breast-feeding
4. Other patients who have been judged inappropriate as research subjects by research managers (including colorectal biopsy cases)
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rikako Kinoshita
Organization Nagasaki University Hospital
Division name Gastroenterology
Zip code
Address 1-7-1 Sakamoto,Nagasaki-shi,Nagasaki,Japan
TEL 0958197482
Email toto.rikako@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Rikako Kinoshita
Organization Nagasaki University Hospital
Division name Gastroenterology
Zip code
Address 1-7-1 Sakamoto,Nagasaki-shi,Nagasaki,Japan
TEL 0958197482
Homepage URL
Email toto.rikako@gmail.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Nagasaki University Hospital
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
2018 Year 11 Month 26 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
2018 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Oncostatin M and phosphorylated STAT in colonic biopsy tissue before and after treatment for patients treated with tofacitinib for ulcerative colitis were measured by ELISA and it could be a biomarker for prognostic prediction Will be examined. In addition, RNA is collected from colon biopsy tissue before and after treatment, comprehensive analysis of microRNA is performed, and a biomarker for new prognostic prediction is searched.

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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