UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001484
Receipt No. R000001802
Scientific Title The establishment of clinical markers using plasma aminogram in the patients of inflammatory bowel disease
Date of disclosure of the study information 2008/11/08
Last modified on 2008/11/07

* 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 establishment of clinical markers using plasma aminogram in the patients of inflammatory bowel disease
Acronym The establishment of clinical markers using plasma aminogram in the patients of inflammatory bowel disease
Scientific Title The establishment of clinical markers using plasma aminogram in the patients of inflammatory bowel disease
Scientific Title:Acronym The establishment of clinical markers using plasma aminogram in the patients of inflammatory bowel disease
Region
Japan

Condition
Condition Inflammatory bowel disease; (crohn's disease; CD, ulcerative colitis; UC)
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We establish clinical markers for clinical use from the results of analysis of plasma amino acid concentrations in the patients of inflammatory bowel disease.
Basic objectives2 Others
Basic objectives -Others The establishment of clinical markers
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes "Amino-Index"
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 patients fulfilling all of the following criteria were subjected to the survey.
1. UC and CD patients who matched the diagnosis of specific disease investigation committee of Japanese ministry of health, labor and welfare and are patients in Keio University Hospital.
2. Patients of either gender
3. Patients who understood the purpose of experiment and signed a consent form.
Key exclusion criteria 1. When the patient does not agree to the experiment.
2. When the doctor determines that the survey is not medically or ethically adequate to the patient.
3.The patients who have meals before taking a blood sample.
4.The patients who are treated by IVH or amino acids preparations.
Target sample size 1300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisamatsu Tadakazu
Organization School of Medicine, Keio University
Division name Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisamatsu Tadakazu
Organization School of Medicine, Keio University
Division name Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email hisamachi@a7.keio.jp

Sponsor
Institute Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Ajinomoto. Co., Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Ministry of Health, Labour and Welfare

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
2008 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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
Date of protocol fixation
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information case-control study

Management information
Registered date
2008 Year 11 Month 07 Day
Last modified on
2008 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001802

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.