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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038806
Receipt No. 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 2019/12/09

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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
Email 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 101-0021
Address Gakki-Kaikan Room #101, 2-18-21 Soto-Kanda, Chiyoda-ku, Tokyo,
TEL 03-5294-7288
Homepage URL
Email office-bc@cspor-bc.or.jp

Sponsor
Institute Comprehensive Support Project for Oncological Research of Breast Cancer
Institute
Department

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
Email 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
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
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
2022 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
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044243

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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