UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041697 |
|---|---|
| Receipt number | R000047598 |
| Scientific Title | Creation of cytochrome P450 genotyping panel. |
| Date of disclosure of the study information | 2020/09/06 |
| Last modified on | 2024/03/14 10:25:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Creation of cytochrome P450 genotyping panel.
Acronym
Creation of cytochrome P450 genotyping panel.
Scientific Title
Creation of cytochrome P450 genotyping panel.
Scientific Title:Acronym
Creation of cytochrome P450 genotyping panel.
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To create volunteer panel of known polymorphism of CYP2C9, CYP2C19, CYP2D6 for future use in clinical studies.
Basic objectives2
Others
Basic objectives -Others
To create genotyping panel
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Polymorphism (CYP2C9, CYP2C19, CYP2D6)
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
1, A Japanese male/ female subject who gives written consent to the study.
Key exclusion criteria
1, A subject whose blood is difficult to collect.
2, A subject who the investigators think is not appropriate to the study.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Matsuki |
Organization
SOUSEIKAI Fukuoka Mirai Hospital
Division name
Clinical Research Center
Zip code
813-0017
Address
3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL
0926623608
shunji-matsuki@lta-med.com
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Matsuzaki |
Organization
SOUSEIKAI Fukuoka Mirai Hospital
Division name
Clinical Research Center
Zip code
813-0017
Address
3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL
0926623608
Homepage URL
yukie-matsuzaki@lta-med.com
Sponsor or person
Institute
SOUSEIKAI Fukuoka Mirai Hospital
Institute
Department
Personal name
Funding Source
Organization
SOUSEIKAI Fukuoka Mirai Hospital
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
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
0922837701
miyako-koga@lta-med.com
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
| 2020 | Year | 09 | Month | 06 | 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
267
Results
IC obtained 267
blood sample collected 244
Results date posted
| 2024 | Year | 03 | Month | 14 | Day |
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
| 2020 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To create volunteer panel of known polymorphism of CYP2C9, CYP2C19, CYP2D6 for future use in clinical studies.
Management information
Registered date
| 2020 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047598
