UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001484
Receipt number 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 15:17:38

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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 or person

Institute

Department of Internal Medicine, School of Medicine, Keio University

Institute

Department

Personal name



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

Value
https://center6.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