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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046611
Receipt No. R000053171
Scientific Title Evaluation of association of HLA and ABCG2 alleles with Severe interstitial lung disease (ILD) and hepatotoxicity in patients receiving abemaciclib
Date of disclosure of the study information 2022/01/14
Last modified on 2022/01/12

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Basic information
Public title Evaluation of association of HLA and ABCG2 alleles with Severe interstitial lung disease (ILD) and hepatotoxicity in patients receiving abemaciclib
Acronym Evaluation of association of HLA and ABCG2 alleles with ILD and hepatotoxicity in patients receiving abemaciclib
Scientific Title Evaluation of association of HLA and ABCG2 alleles with Severe interstitial lung disease (ILD) and hepatotoxicity in patients receiving abemaciclib
Scientific Title:Acronym Evaluation of association of HLA and ABCG2 alleles with ILD and hepatotoxicity in patients receiving abemaciclib
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 investigate the association of HLA and ABCG2 alleles with ILD and hepatotoxicity in patients receiving abemaciclib.
Basic objectives2 Others
Basic objectives -Others To explore risk factors
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To assess the association of HLA and ABCG2 alleles with abemaciclib-induced ILD
Key secondary outcomes To assess the association of HLA and ABCG2 alleles with abemaciclib-induced hepatotoxicity

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 Patients for the secondary research in the nested case control study of abemaciclib-induced interstitial lung disease (NOSIDE).
Key exclusion criteria Not specified
Target sample size 236

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 03-3784-8145
Email 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 03-3784-8145
Homepage URL
Email imamurack@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor CSPOR-BC
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
Email 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 昭和大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 14 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 Preinitiation
Date of protocol fixation
2021 Year 12 Month 10 Day
Date of IRB
2021 Year 12 Month 23 Day
Anticipated trial start date
2022 Year 01 Month 20 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case-control study

Management information
Registered date
2022 Year 01 Month 12 Day
Last modified on
2022 Year 01 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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