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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040357
Receipt No. 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 2020/05/11

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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
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 Tomohiko
Middle name
Last name Aihara
Organization CSPOR-BC
Division name Office
Zip code 101-0021
Address 2-18-21Sotokanda_Chiyodaku_Tokyo
TEL 03-5294-7288
Homepage URL
Email office-bc@cspor-bc.or.jp

Sponsor
Institute SHOWA University
Advanced Cancer Treatment Laboratory
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 SHOWA University
Address 1-5-8 Hatanodai Shinagawa-ku Tokyo
Tel 03-3784-8000
Email tsurutaj@med.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

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 Open public recruiting
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
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.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


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