UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043235 |
|---|---|
| Receipt number | R000049333 |
| Scientific Title | An exploratoly study to evaluate biomarkers in cell free DNA of "Sequential therapy from afatinib to osimertinib for EGFR mutant non small cell lung cancer: a multicenter prospective observational study (Gio Tag Japan)". |
| Date of disclosure of the study information | 2021/02/03 |
| Last modified on | 2021/02/03 08:27:29 |
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Basic information
Public title
An exploratoly study to evaluate biomarkers in cell free DNA of "Sequential therapy from afatinib to osimertinib for EGFR mutant non small cell lung cancer: a multicenter prospective observational study (Gio Tag Japan)".
Acronym
Biomarker study in cell free DNA of Gio-Tag Japan.
Scientific Title
An exploratoly study to evaluate biomarkers in cell free DNA of "Sequential therapy from afatinib to osimertinib for EGFR mutant non small cell lung cancer: a multicenter prospective observational study (Gio Tag Japan)".
Scientific Title:Acronym
Biomarker study in cell free DNA of Gio-Tag Japan.
Region
| Japan |
Condition
Condition
non-small cell lung cancer(EGFR mutation positive)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore biomarkers using Cell free DNA (cfDNA) that predict the efficacy of sequential therapy from afatinib to osimertinib
Basic objectives2
Others
Basic objectives -Others
Biomarker research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlation between the presence or absence of compound mutations in cfDNA and the duration of treatment with sequential therapy from afatinib to osimertinib
Key secondary outcomes
1) To evaluate the correlation between the presence or absence of compound mutations in cfDNA at resistance to afatinib and the duration of afatinib treatment
2) To evaluate the correlation between the presence or absence of compound mutations in cfDNA before afatinib treatment and the duration of osimertinib treatment
3) To evaluate the correlation between the presence or absence of compound mutations in cfDNA and overall survival
4) To evaluate changes in compound mutations before afatinib and at resistance
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 Gio-Tag Japan study
Key exclusion criteria
None
Target sample size
93
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Katakami |
Organization
Takarazuka City Hospital
Division name
Department of Medical Oncology
Zip code
665-0827
Address
5-1, 4 chome, Kohama, Takarazuka
TEL
0797-87-1161
nkatakami1954@gmail.com
Public contact
Name of contact person
| 1st name | Hideharu |
| Middle name | |
| Last name | Kimura |
Organization
Kanazawa University Hospital
Division name
Respiratory Medicine
Zip code
920-8641
Address
Takara-machi 13-1, Kanazawa, Ishikawa
TEL
076-265-2000
Homepage URL
hkimura3625@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
HANSHIN Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim
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
Takarazuka City Hospital
Address
5-1, 4 chome, Kohama, Takarazuka
Tel
0797-87-1161
klog@jcom.zaq.ne.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 | 02 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Biomarker study of prospective observational study
Management information
Registered date
| 2021 | Year | 02 | Month | 03 | Day |
Last modified on
| 2021 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049333
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
