UMIN-CTR Clinical Trial

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

inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES

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

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

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

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

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

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

Institute

Shiga University of Medical Science

Institute

Department

Personal name

Organization

Shiga University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2015

Year

08

Month

17

Day

URL releasing protocol

Publication of results

Published

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

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 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).

Registered date

2015

Year

08

Month

14

Day

Last modified on

2016

Year

08

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021608