UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination about the susceptibility of the FTO gene single nucleotide polymorphism for leukopenia by the thiopurine in the inflammatory bowel disease.
Title of the study (Brief title)	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	Hirotsugu Imaeda
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
Address	Setatsukinowa, Otsu
TEL	077-548-2217
Email	imaeda@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hirotsugu Imaeda
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
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
Institute	Division of Gastroenterology, Department of Medicine, Shiga University of Medical Science
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028341