UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043299 |
|---|---|
| Receipt number | R000049415 |
| Scientific Title | An ancillary biomarker study of Gio-Tag Japan. |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2021/02/10 19:18:25 |
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Basic information
Public title
An ancillary biomarker study of Gio-Tag Japan.
Acronym
An ancillary biomarker study of Gio-Tag Japan.
Scientific Title
An ancillary biomarker study of Gio-Tag Japan.
Scientific Title:Acronym
An ancillary biomarker study of Gio-Tag Japan.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Identifying Factors that Make Patients Ready for Afatinib to Osimertinib Sequential Therapy
Basic objectives2
Others
Basic objectives -Others
Biomarker study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of T790M rate before and after treatment with afatinib.
Key secondary outcomes
Correlation between T790M rate before treatment with afatinib and response rate, progression-free survival, and overall survival of afatinib.
Correlation between the T790M rate before the treatment with afatinib and the transition rate to second-line treatment.
Correlation between T790M rate before treatment with afatinib, and response rate and progression-free survival rate of second-line treatment.
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
Patients enrolled in the main study (Gio-Tag Japan) (UMIN000037452)
Key exclusion criteria
Patients with no residual specimens collected in the main study (Gio-tag Japan)
Patients whose data was rejected in the main study
Target sample size
93
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kijima |
Organization
Hyogo College of Medicine Hospital
Division name
Respiratory Medicine
Zip code
663-8501
Address
1-1,mukogawacho,nishinomiya
TEL
0798-45-6597
tkijima@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yokoi |
Organization
Hyogo College of Medicine Hospital
Division name
Respiratory Medicine
Zip code
663-8501
Address
1-1,mukogawacho,nishinomiya
TEL
0798-45-6597
Homepage URL
ta-yokoi@hyo-med.ac.jp
Sponsor or person
Institute
HANSHIN Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co.Ltd.
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
Hyogo College of Medicine
Address
1-1,mukogawacho,nishinomiya
Tel
0798-45-6066
rinri@hyo-med.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
全国から約60施設
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 15 | 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
93
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 26 | 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
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2021 | Year | 02 | Month | 10 | Day |
Last modified on
| 2021 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049415
