UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015784 |
|---|---|
| Receipt number | R000018369 |
| Scientific Title | Genome analysis on drug adverse reaction |
| Date of disclosure of the study information | 2014/11/28 |
| Last modified on | 2021/08/26 20:12:50 |
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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
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
takiguchi@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Medical Oncology
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018369
