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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024635
Receipt No. 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

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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
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)

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028341

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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