UMIN-CTR Clinical Trial

Basic information
Public title	Genome analysis on drug adverse reaction
Acronym	Genome analysis on drug adverse reaction
Scientific Title	Genome analysis on drug adverse reaction
Scientific Title:Acronym	Genome analysis on drug adverse reaction
Region	Japan

Condition
Condition	Malignant diseases
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To elucidate genetic basis of unreported/serious adverse effects by anti-neoplastic agents, genome (exome, whole genemo) analyses are performed.
Basic objectives2	Others
Basic objectives -Others	Genome analyses
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between drug adverse reactions and genome information.
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	Individuals experienced unreported/serious adverse reaction caused by anti-neoplastic agents.
Key exclusion criteria	Not applicable
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takiguchi, Yuichi
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Medical Oncology
Zip code
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-226-2806
Email	takiguchi@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Takiguchi, Yuichi
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Medical Oncology
Zip code
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-226-2806
Homepage URL
Email	takiguchi@faculty.chiba-u.jp

Sponsor
Institute	Department of Medical Oncology Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Genome Biology, Kinki University School of Medicine
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	千葉大学大学院医学研究院（千葉県）

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 28 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	Terminated
Date of protocol fixation	2013 Year 05 Month 24 Day
Date of IRB	2013 Year 05 Month 28 Day
Anticipated trial start date	2013 Year 05 Month 30 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	Analyses are performed by individual case upon occurrence of unreported/serious drug adverse reaction.

Management information
Registered date	2014 Year 11 Month 28 Day
Last modified on	2021 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018369