UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000040357
Receipt number	R000046053
Scientific Title	Nested Case Control Study of Abemaciclib-induced Interstitial Lung Disease
Date of disclosure of the study information	2020/05/11
Last modified on	2023/03/22 13:43:13

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Basic information

Public title

Nested Case Control Study of Abemaciclib-induced Interstitial Lung Disease

Acronym

NOSIDE

Scientific Title

Nested Case Control Study of Abemaciclib-induced Interstitial Lung Disease

Scientific Title:Acronym

NOSIDE

Region

Japan

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES

Objectives

Narrative objectives1

To identify the incidence rate severity, clinical disease type, clinical course, and period during which patients are susceptible to the development of Abemaciclib-induced ILD
To exploratively investigate the risk factors and exacerbating factors associated with Abemaciclib-induced ILD

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Incidence rate of Abemaciclib-induced ILD
Risk factors associated with Abemaciclib-induced ILD

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

Male and Female

Key inclusion criteria

Subjects of the primary research
Patients with metastatic breast cancer treated with Abemaciclib during the period from November 1 2018 to December 31 2019
Subjects of the secondary research
The Cases are determined as those reported as having Abemaciclib-induced ILD in the primary research including suspected cases and matched cases without Abemaciclib-induced ILD are selected as Controls.
Subjects of the nested case control study
Case presented with Abemaciclib-induced ILD: Among the cases accumulated for the primary research, those determined to have Abemaciclib-induced ILD by the Central Evaluation Committee. Evaluation criteria used in the Central Evaluation Committee are set forth separately.
Control presented with no Abemaciclib-induced ILD Among the cases accumulated for the primary research, those who did not develop Abemaciclib-induced ILD and whose clinicopathological background is matched to that of cases developed Abemaciclib-induced ILD i.e Case.
Cases of subjects whose existing information is approved by the subjects themselves or their proxies to be used for research purpose.
Cases in which subjects received an explanation of the study contents and if obtaining informed consent from these subjects is difficult those in which subjects do not refuse the use of their clinical information. Obtaining informed consent from the subjects themselves can be omitted.

Key exclusion criteria

None

Target sample size

2000

Research contact person

Name of lead principal investigator

1st name Junji

Middle name

Last name Tsurutani

Organization

SHOWA University

Division name

Advanced Cancer Treatment Laboratory

Zip code

142-8666

Address

1-5-8 Hatanodai Shinagawa-ku Tokyo

TEL

03-3784-8000

Email

tsurutaj@med.showa-u.ac.jp

Public contact

Name of contact person

1st name Office

Middle name

Last name CSPOR-BC

Organization

CSPOR-BC

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

SHOWA University
Advanced Cancer Treatment Laboratory

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

SHOWA University

Address

1-5-8 Hatanodai Shinagawa-ku Tokyo

Tel

03-3784-8000

Email

tsurutaj@med.showa-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 11 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

Completed

Date of protocol fixation

2020 Year 01 Month 27 Day

Date of IRB

2020 Year 03 Month 27 Day

Anticipated trial start date

2020 Year 04 Month 16 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

None

Management information

Registered date

2020 Year 05 Month 11 Day

Last modified on

2023 Year 03 Month 22 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046053

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name