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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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


Email

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name