UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017831
Receipt number R000020655
Scientific Title Research for new biomarker about diagnosis and evaluation of disease condition for inflammatory bowel disease (IBD).
Date of disclosure of the study information 2015/08/01
Last modified on 2023/12/11 15:00:04

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Basic information

Public title

Research for new biomarker about diagnosis and evaluation of disease condition for inflammatory bowel disease (IBD).

Acronym

Research for new biomarker of inflammatory bowel disease (IBD)

Scientific Title

Research for new biomarker about diagnosis and evaluation of disease condition for inflammatory bowel disease (IBD).

Scientific Title:Acronym

Research for new biomarker of inflammatory bowel disease (IBD)

Region

Japan


Condition

Condition

Inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Recently, for diagnosis and the evaluation of inflammatory bowel disease (IBD), the effectiveness of noninvasive examination such as CT, MRI, and blood CRP level instead of invasive colonoscopy examination has been evaluated. However, the effectiveness of these examination has not been elucidated yet. In this study, using blood trace element, fibrosis marker, oxidative related marker, immunologic marker, and stool marker such as calprotectin, fecal occult blood, we aimed to research new biomarker for IBD patients to diagnose and evaluation of disease condition.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate the correlation between endoscopic disease condition and biomarkers after one week of sampling.

Key secondary outcomes

To evaluate the change of biomarkers by the treatment for IBD.


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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients diagnosed as ulcerative colitis and Crohn's disease based on the criteria of Japanese Ministry of Health, Specific disease intractable inflammation-related intestinal tract disorder research group.

Key exclusion criteria

a) Re-registration example to the examination
b) The patients with malignant tumor
c) The patients with surgical operation within 12 weeks
d) In addition, the patient who judged an arrangement to the examination if the medical attendant was inappropriate

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan

TEL

075-251-5519

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Tomohisa
Middle name
Last name Takagi

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajiicho Kawaramachidori Kamigyo-ku Kyoto, Japan Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Ky

TEL

075-251-5519

Homepage URL


Email

k-uchi@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan

Tel

075-251-5337

Email

rinri@koto.kpu-m.ac.jp


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

2015 Year 08 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

2015 Year 08 Month 01 Day

Date of IRB

2015 Year 12 Month 18 Day

Anticipated trial start date

2015 Year 12 Month 25 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The entry of patients will be dome from now.


Management information

Registered date

2015 Year 06 Month 06 Day

Last modified on

2023 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020655


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name