UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060694 |
|---|---|
| Receipt number | R000069366 |
| Scientific Title | Prospective evaluation of an HLA-X as a biomarker for abemaciclib-induced hepatotoxicity (confirmatory study) |
| Date of disclosure of the study information | 2026/02/17 |
| Last modified on | 2026/02/17 13:31:26 |
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Basic information
Public title
Prospective evaluation of a biomarker for abemaciclib-induced hepatotoxicity (confirmatory study)
Acronym
Evaluation of a biomarker for abemaciclib-induced hepatotoxicity (confirmatory study)
Scientific Title
Prospective evaluation of an HLA-X as a biomarker for abemaciclib-induced hepatotoxicity (confirmatory study)
Scientific Title:Acronym
Prospective evaluation of a biomarker for abemaciclib-induced hepatotoxicity (confirmatory study)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate an identified HLA allele as a biomarker for abemaciclib-induced hepatotoxicity.
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 an identified HLA allele with ALT increased of grade 2/3/4.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Breast cancer patients starting to treat with abemaciclib at 300 mg/day within two weeks.
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Chiyo |
| Middle name | K. |
| Last name | Imamura |
Organization
Saitama Cancer Center
Division name
Department of Medical Genetics and Genomics
Zip code
362-0806
Address
780 Komuro, Ina-machi, Kitaadachi-gun, Saitama
TEL
048-722-1111
imamura.chiyo@saitama-pho.jp
Public contact
Name of contact person
| 1st name | Chiyo |
| Middle name | K. |
| Last name | Imamura |
Organization
Saitama Cancer Center
Division name
Department of Medical Genetics and Genomics
Zip code
362-0806
Address
780 Komuro, Ina-machi, Kitaadachi-gun, Saitama
TEL
048-722-1111
Homepage URL
imamura.chiyo@saitama-pho.jp
Sponsor or person
Institute
Saitama Cancer Center
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Saitama Cancer Center
Address
780 Komuro, Ina-machi, Kitaadachi-gun, Saitama
Tel
048-722-1111
imamura.chiyo@saitama-pho.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
| 2026 | Year | 02 | Month | 17 | 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
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2029 | Year | 02 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular.
Management information
Registered date
| 2026 | Year | 02 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069366
