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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005699
Receipt No. R000006739
Scientific Title Prediction of therapeutic effect for refractory ulcerative colitis by measuring cytokines in colon lesion tissue and blood
Date of disclosure of the study information 2011/06/01
Last modified on 2013/05/16

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Basic information
Public title Prediction of therapeutic effect for refractory ulcerative colitis by measuring cytokines in colon lesion tissue and blood
Acronym Prediction of therapeutic effect for refractory UC by measuring cytokines in colon and blood
Scientific Title Prediction of therapeutic effect for refractory ulcerative colitis by measuring cytokines in colon lesion tissue and blood
Scientific Title:Acronym Prediction of therapeutic effect for refractory UC by measuring cytokines in colon and blood
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Finding factors for prediction of therapeutic effect of immunosupressive medications and anti-TNF alpha antibody for refractory ulcerative colitis by measuring cytokines in rectal mucosa and blood.
Basic objectives2 Others
Basic objectives -Others Prediction of therapeutic efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relaion between cytokines in rectal mucosa and blood and clinical improvement assesed by endoscopic findings and clinical symptoms.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The objects are patients diagnosed with ulcerative colitis by the diagnostic criteria of Japanese Health, Labour and Welfare Ministry. The purpose and nature of this study are explained to each subject, and written informed consent must be obtained.
Key exclusion criteria Those patients who do not consent to this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadakazu Hisamatsu
Organization Keio University, School of Medicine
Department of Internal Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University, School of Medicine Department of Internal Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address
TEL 03-5363-3790
Homepage URL
Email

Sponsor
Institute Keio University, School of Medicine
Department of Internal Medicine
Division of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Keio University, School of Medicine
Department of Internal Medicine
Division of Gastroenterology and Hepatology
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
2011 Year 06 Month 01 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 Completed
Date of protocol fixation
2011 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Rectal mucosa and blood are collected when the colonoscopy is performed.

Management information
Registered date
2011 Year 06 Month 01 Day
Last modified on
2013 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006739

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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