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
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
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
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
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
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
