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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018675
Receipt No. R000021608
Scientific Title Analysis of NUDT15 gene polymorphism in inflammatory bowel disease patients
Date of disclosure of the study information 2015/08/17
Last modified on 2016/08/15

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Basic information
Public title Analysis of NUDT15 gene polymorphism in inflammatory bowel disease patients
Acronym Analysis of NUDT15 gene polymorphism in inflammatory bowel disease patients
Scientific Title Analysis of NUDT15 gene polymorphism in inflammatory bowel disease patients
Scientific Title:Acronym Analysis of NUDT15 gene polymorphism in inflammatory bowel disease patients
Region
Japan

Condition
Condition inflammatory bowel disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study is evaluated relation between the NUDT15,TPMT,MRP4,ITPA gene polymorphism, 6-thioguanine nucleotide(6TGN) concentration and thiopurine-induced leukopenia in the IBD patients treated with Azathioprine(AZA)/6-mercaptopurine(6MP).
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NUDT15 gene polymorphism is analyzed.And WBC count(2,4,8weeks),Interval from onset of AZA/6MP therapy to leukopenia, AZA/6MP dose is evaluated.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria inflammatory bowel disease(IBD) patients
Key exclusion criteria 1)pregnancy
2)history of drug allergy
3)patients not approving the study consent
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Andoh
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta Tsukinowa, Otsu, Shiga
TEL 077-548-2217
Email andoh@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Nishida
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta Tsukinowa, Otsu, Shiga
TEL 077-548-2217
Homepage URL
Email atsuda@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical Science
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26590936
Number of participants that the trial has enrolled
Results The NUDT15 C/C, C/T, and T/T genotypes were 80.7, 18.2, and 1.1%, respectively.The allelic frequency was 10.2%. Among 161 IBD patients, there was no significant difference in 6-TGN levels among the NUDT15 genotypes.Forty-five patients (27.9%) developed leukocytopenia (WBC<3000/ul), and the C/T and T/T genotypes were significantly associated with the development of leukocytopenia (P=1.7 X 10(-5)). )). In these patients, 6-TGN levels were not significantly different between NUDT15 genotypes. NUDT15 R139C was significantly associated with early (<8 weeks) (P = 1.03 X 10(-4)) and late (>8 weeks) leukocytopenia (P = 4.3 X 10(-4)). The decrease in WBC count at 2 and 4 weeks was significantly higher in patients with the C/T or T/T genotypes as compared to the patients with the C/C genotype. All patients with the T/T genotype (n = 2) developed early severe hair loss and severe leukocytopenia (<1000/ul). The logistic regression analysis revealed that NUDT15 R139C was the sole genetic factor responsible for the thiopurine-induced leukocytopenia (P = 0.001).
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 Main results already published
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 04 Month 01 Day

Other
Other related information Retrospective study.
This study is evaluated relation between the NUDT15,TPMT,MRP4,ITPA gene polymorphism, AZA/6MP dose, 6TGN concentration and thiopurine-induced leukopenia in the IBD patients treated with Azathioprine(AZA)/6-mercaptopurine(6MP).

Management information
Registered date
2015 Year 08 Month 14 Day
Last modified on
2016 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021608

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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