UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034321 |
|---|---|
| Receipt number | R000039126 |
| Scientific Title | A retrospective study of interstitial lung disease due to EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/04/07 17:38:16 |
* 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
A retrospective study of interstitial lung disease due to EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor
Acronym
NEJ040
Scientific Title
A retrospective study of interstitial lung disease due to EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor
Scientific Title:Acronym
NEJ040
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate reasonable sequence and interval to use EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor for patients with non-small cell lung cancer harboring EGFR mutation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationships between sequence/interval to use EGFR tyrosine kinase inhibitor and immune checkpoint inhibitor, and frequency/severity of interstitial lung disease
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
1.non-small cell lung cancer with EGFR mutations
2.To have treatment history using EGFR tyrosine kinase inhibitor and immune check poinnt inhibitor
Key exclusion criteria
non
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Department of Respiratory Medicine
Zip code
113-8431
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL
03-3813-3111
kztakaha@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Ko |
Organization
Juntendo University
Division name
Department of Respiratory Medicine
Zip code
113-8431
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
rkou@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo IRB
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.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
| 2018 | Year | 10 | Month | 01 | 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
235
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
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Survey Components
Patient characteristics, information of survival, information of treatment, information of interstitial lung disease
Management information
Registered date
| 2018 | Year | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039126
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
