UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044854 |
|---|---|
| Receipt number | R000051155 |
| Scientific Title | A retrospective observational study of investigating the real world data of post-treatment after drug-induced lung injury by osimertinib and the safety and efficacy of EGFR-TKI re-challenge |
| Date of disclosure of the study information | 2021/07/13 |
| Last modified on | 2021/07/13 18:47:46 |
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Basic information
Public title
A retrospective observational study of investigating the real world data of post-treatment after drug-induced lung injury by osimertinib and the safety and efficacy of EGFR-TKI re-challenge
Acronym
Osi-risk study
Scientific Title
A retrospective observational study of investigating the real world data of post-treatment after drug-induced lung injury by osimertinib and the safety and efficacy of EGFR-TKI re-challenge
Scientific Title:Acronym
Osi-risk study
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 the efficacy and safety of EGFR-TKI rechallenge after second or later line therapy in non-small cell lung cancer patients who have previously suffered drug-induced lung injury due to Osimertinib administration in first-line therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative incidence of drug-induced lung injury at 3, 6, and 12 months after initiation of EGFR-TKI rechallenge
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
Non small cell lung cancer patients who received Osimertinib as first-line therapy and who experienced clinical drug-induced lung injury
Key exclusion criteria
Patients participating in studies aimed at similar analysis of treatment after Osimertinib
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hisao |
| Middle name | |
| Last name | Imai |
Organization
Saitama Medical University International Medical Center
Division name
Respiratory Medicine
Zip code
350-1298
Address
1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL
042-984-4177
hisao725@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Nishioka |
Organization
Shizuoka cancer center
Division name
Thoracic Oncology
Zip code
411-8777
Address
1007, Shimo-nagakubo,Sunto-gun,Shizuoka
TEL
055-989-5222
Homepage URL
n.nishioka@scchr.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka cancer center
Address
1007, Shimo-nagakubo,Sunto-gun,Shizuoka
Tel
055-989-5222
irb@scchr.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
| 2021 | Year | 07 | Month | 13 | 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
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 07 | Month | 13 | Day |
Last modified on
| 2021 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051155
