UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038806 |
|---|---|
| Receipt number | R000044243 |
| Scientific Title | Observational Study of Drug-Induced Lung Injury Caused by Abemaciclib |
| Date of disclosure of the study information | 2019/12/10 |
| Last modified on | 2024/02/08 18:21:03 |
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Basic information
Public title
Observational Study of Drug-Induced Lung Injury Caused by Abemaciclib
Acronym
Observational Study of Drug-Induced Lung Injury Caused by Abemaciclib
Scientific Title
Observational Study of Drug-Induced Lung Injury Caused by Abemaciclib
Scientific Title:Acronym
Observational Study of Drug-Induced Lung Injury Caused by Abemaciclib
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Endocrine surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence, severity, clinical course, and risk factors for drug-induced lung injury due to abemaciclib in a prospective study
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of drug-induced lung injury due to abemaciclib
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
Female
Key inclusion criteria
1) Women from whom consent to participate in the Observational Study of Abemaciclib for Chemotherapy-Treated Metastatic Breast Cancer, which is currently being conducted by the CSPOR-BC, is obtained
2) Women from whom written consent to participate in this ancillary study is obtained
Key exclusion criteria
1) Women who are judged by their physicians in charge to be ineligible for any reason.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Araki |
Organization
Gunma Prefectural Cancer Center
Division name
Department of Medical Oncology
Zip code
373-0828
Address
617-1akabayashinisimachi Otashi Gunma
TEL
0276-38-0771
kaz-araki@gunma-cc.jp
Public contact
Name of contact person
| 1st name | Comprehensive Support Project for Oncological Rese |
| Middle name | |
| Last name | CSPOR-BC |
Organization
Comprehensive Support Project for Oncological Research of Breast Cancer
Division name
Office
Zip code
277-0871
Address
Satellite no.502 in front of Kashiwanoha Campus, The University of Tokyo, 178-4-4 Wakashiba, Kashiwa
TEL
04-7135-5609
Homepage URL
office-bc@cspor-bc.or.jp
Sponsor or person
Institute
Comprehensive Support Project for Oncological Research of Breast Cancer
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Prefectural Cancer Center
Address
617-1Takabayashinisimachi Otashi Gunma
Tel
0276-38-0771
kaz-araki@gunma-cc.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
| 2019 | Year | 12 | Month | 10 | 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
130
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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2019 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044243
