UMIN-CTR Clinical Trial

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

Ulcerative colitis

Classification by specialty

Medicine in general

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

滋賀医科大学附属病院

Date of disclosure of the study information

2016

Year

11

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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)

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