UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024635
Receipt number R000028341
Scientific Title Examination about the susceptibility of the FTO gene single nucleotide polymorphism for leukopenia by the thiopurine in the inflammatory bowel disease.
Date of disclosure of the study information 2016/11/03
Last modified on 2018/11/20 21:55:33

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Basic information

Public title

Examination about the susceptibility of the FTO gene single nucleotide polymorphism for leukopenia by the thiopurine in the inflammatory bowel disease.

Acronym

AZAFTO

Scientific Title

Examination about the susceptibility of the FTO gene single nucleotide polymorphism for leukopenia by the thiopurine in the inflammatory bowel disease.

Scientific Title:Acronym

AZAFTO

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The number of patients of the inflammatory bowel disease represented by ulcerative colitis and Crohn's disease increased year by year, and, as for the ulcerative colitis, 140,000 people, Crohn's disease became the place more than 30,000.
However, the inflammatory bowel disease does not lead to the identification of the etiology at present, and it is said that the immunoreactive abnormality in the induced gastrointestinal tract is more likely to be associated by a genetic predisposition and an environmental predisposition.
These disease develops a lot in young people and the administration of biological preparation and immunosuppressive drug is necessary and may be sometimes forced to surgery for a long term.
As for the representative thing, there is calcinurine inhibitor such as a thiopurine preparation and the tacrolimus such as azathioprine and the 6-mercaptopurine with an immunosuppressive drug given for inflammatory bowel disease.
In late years it was found that there was much side effect frequency of leukopenia and alopecia when the gene called NUDT15 had mutation called R139C.
However, it is found that the patients presenting with significant leukopenia without mutation in NUDT15 gene exist, and the presence of other genes is suggested.
Also, Kim et al. reported that the mutation of a gene called fat mass and obesity-associated (FTO) and the gene called runt related transcription factor 1 (RUNX1) was associated with leukopenia in 2016.
This study identifies that gene single nucleotide polymorphism (SNPs) of RUNX1 is one of the predictors of the adverse event with the thiopurine preparation as FTO and is intended that we apply a clinic as a marker to determine an injection method and a dose.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

If it is found that gene single nucleotide polymorphism (SNPs) of FTO and RUNX1 is one of the predictors of the adverse event with the thiopurine preparation by this study in addition to NUDT15, safety will be secured for treatment preferences of the inflammatory bowel disease by clinical application.

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

16 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Age is one younger than 65 years 16 years old or older
(2) The patients who had a diagnosis of Crohn's disease or ulcerative colitis
(3) It is among internal use or internal use due to begin one with thiopurine preparation (azathioprine, 6-mercaptopurine) now.

Key exclusion criteria

(1) One in this hospital without the plan of the examination of drawing blood.
(2) In the one that has already taken thiopurine preparation, thiopurine preparation is internal use start and the that there are not blood data when it was.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotsugu Imaeda

Organization

Shiga University of Medical Science

Division name

Division of Gastroenterology, Department of Medicine

Zip code


Address

Setatsukinowa, Otsu

TEL

077-548-2217

Email

imaeda@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirotsugu Imaeda

Organization

Shiga University of Medical Science

Division name

Division of Gastroenterology, Department of Medicine

Zip code


Address

Setatsukinowa, Otsu

TEL

077-548-2217

Homepage URL

http://www.ninai-sums.jp/study/gastrointestinal-medicine

Email

imaeda@belle.shiga-med.ac.jp


Sponsor or person

Institute

Division of Gastroenterology, Department of Medicine,
Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

滋賀医科大学附属病院


Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 03 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

Open public recruiting

Date of protocol fixation

2016 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 06 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information

rs16957920 (FTO intron), rs2834826 (RUNX1 intergenic), rs79206939 (FTO p.Ala134Thr), rs116855232 (NUDT15 p.Arg139Cys), rs554405994 (NUDT15 p.Val18_Val19insGlyVal), rs147390019 (NUDT15 p.Arg139His), rs186364861 (NUDT15 p.Val18Ile)


Management information

Registered date

2016 Year 10 Month 30 Day

Last modified on

2018 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028341