UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044863 |
|---|---|
| Receipt number | R000050892 |
| Scientific Title | Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease |
| Date of disclosure of the study information | 2021/07/19 |
| Last modified on | 2023/01/13 15:10:43 |
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Basic information
Public title
Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease
Acronym
Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease
Scientific Title
Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease
Scientific Title:Acronym
Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency of drug-induced lung disease in patients with advanced non-small cell lung cancer, EGFR mutation positive, and treated with Osimertinib as first-line therapy, based on retrospectively collected data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the frequency of drug-induced 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients for whom information on medical treatment and prognosis can be obtained from medical records.
2.Patients with a confirmed diagnosis of non-small cell lung cancer and positive EGFR mutation who received Osimertinib as first-line therapy
3.Patients who are 20 years old or older.
Key exclusion criteria
1.Patients who have requested not to participate in this study based on the published information.
2.Patients who are currently participating or will participate in clinical research involving interventions related to pharmacotherapy.
3.Other patients who are judged ineligible by the principal investigator.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Tachihara |
Organization
Kobe University Graduates School of Medicine
Division name
Division of Respiratory Medicine/Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo
TEL
078-382-5660
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Mimura |
Organization
Kobe University Hospital
Division name
Division of Respiratory Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo
TEL
078-382-5660
Homepage URL
f9s5m1s3@gmail.com
Sponsor or person
Institute
Kobe University Graduates School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
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
KOBE University Hospital Clinical Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo
Tel
078-382-6669
f9s5m1s3@gmail.com
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 | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
133
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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The survey sheet will be sent to the facilities that are able to participate in this research study, and the research staff at each facility will enter the survey results, which will then be compiled at the data center.
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050892
