UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002339
Receipt number R000002865
Scientific Title Pharmacogenomics and pharmacokinetics study of drug metabolizing enzyme in patients with severe adverse drug reaction due to anti-neoplastics
Date of disclosure of the study information 2009/08/14
Last modified on 2017/08/20 09:22:37

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Basic information

Public title

Pharmacogenomics and pharmacokinetics study of drug metabolizing enzyme in patients with severe adverse drug reaction due to anti-neoplastics

Acronym

Pharmacogenomics and pharmacokinetics in patients with severe adverse drug reaction

Scientific Title

Pharmacogenomics and pharmacokinetics study of drug metabolizing enzyme in patients with severe adverse drug reaction due to anti-neoplastics

Scientific Title:Acronym

Pharmacogenomics and pharmacokinetics in patients with severe adverse drug reaction

Region

Japan


Condition

Condition

Cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Investigate pharmacogenomics and pharmacokinetics of drug metabolizing enzyme or transporter in patients with severe unpredicable adverse drug reaction

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Genetic polymorphism
drug or metabolite concentration

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with unpredictable severe adverse drug reaction including death due to anti-neoplastics

Key exclusion criteria

Informed consent not obtained

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Ishiguro

Organization

Graduate Schhol of Medicine Kyoto University

Division name

Department of Target Therapy Oncology

Zip code


Address

54 Syogoinkawahara-cho, Sakyo-ku, Kyoto-city

TEL

075-751-4950

Email

hkkishi@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Ishiguro

Organization

Graduate Schhol of Medicine Kyoto University

Division name

Department of Target Therapy Oncology

Zip code


Address

54 Syogoinkawahara-cho, Sakyo-ku, Kyoto-city

TEL

075-751-4950

Homepage URL


Email

hkkishi@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Graduate Schhol of Medicine Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

YES

Study ID_1

G-309

Org. issuing International ID_1

Kyoto University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 08 Month 14 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

Completed

Date of protocol fixation

2009 Year 04 Month 30 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

test genetic polymorphism and drug concentration


Management information

Registered date

2009 Year 08 Month 14 Day

Last modified on

2017 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002865


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name