UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037232 |
|---|---|
| Receipt number | R000042452 |
| Scientific Title | The continuous evaluation of EGFR mutation in EGFR-mutation positive lung cancer patients during EGFR TKI treatment |
| Date of disclosure of the study information | 2019/07/04 |
| Last modified on | 2024/07/05 11:52:54 |
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Basic information
Public title
The continuous evaluation of EGFR mutation in EGFR-mutation positive lung cancer patients during EGFR TKI treatment
Acronym
The continuous evaluation of EGFR mutation during EGFR TKI treatment
Scientific Title
The continuous evaluation of EGFR mutation in EGFR-mutation positive lung cancer patients during EGFR TKI treatment
Scientific Title:Acronym
The continuous evaluation of EGFR mutation during EGFR TKI treatment
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate EGFR mutation status during EGFR TKI treatment
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate EGFR mutation status during EGFR TKI treatment
Key secondary outcomes
To evaluate the efficacy of EGFR TKI treatment and EGFR mutation status
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
non-small cell lung cancer patients carrying EGFR activating mutation
Key exclusion criteria
disagreed patients and patients carrying HBV or HCV
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Yamaoka |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku
TEL
03-3784-8146
yamaoka.t@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Yamaoka |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku
TEL
03-3784-8146
Homepage URL
yamaoka.t@med.showa-u.ac.jp
Sponsor or person
Institute
Advanced Cancer Translational Research Institute
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku
Tel
03-3784-8146
yamaoka.t@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
| 2019 | Year | 07 | Month | 04 | 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
| 2019 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All kinds of EGFR TKIs are accepted.
Management information
Registered date
| 2019 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042452
