UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054091 |
|---|---|
| Receipt number | R000061768 |
| Scientific Title | Evaluation of association of HLA alleles with hepatotoxicity in patients receiving abemaciclib (confirmatory study) |
| Date of disclosure of the study information | 2024/04/08 |
| Last modified on | 2024/04/08 19:22:01 |
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Basic information
Public title
Evaluation of association of HLA alleles with hepatotoxicity in patients receiving abemaciclib (confirmatory study)
Acronym
Evaluation of association of HLA alleles with hepatotoxicity in patients receiving abemaciclib (confirmatory study)
Scientific Title
Evaluation of association of HLA alleles with hepatotoxicity in patients receiving abemaciclib (confirmatory study)
Scientific Title:Acronym
Evaluation of association of HLA alleles with hepatotoxicity in patients receiving abemaciclib (confirmatory study)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association of HLA alleles with hepatotoxicity in patients receiving abemaciclib.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the association of HLA alleles with abemaciclib-induced hepatotoxicity
Key secondary outcomes
nothing
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Breast cancer patients receiving abemaciclib for more than 90 days.
Key exclusion criteria
nothing
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Chiyo |
| Middle name | K. |
| Last name | Imamura |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8146
imamurack@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Chiyo |
| Middle name | K. |
| Last name | Imamura |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8146
Homepage URL
imamurack@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.jp
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
| 2024 | Year | 04 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Association between HLA alleles and grade 2/3 ALT elevation will be evaluated.
Management information
Registered date
| 2024 | Year | 04 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061768
