UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024476 |
|---|---|
| Receipt number | R000028172 |
| Scientific Title | Resistant mechanisms to afatinib in non-small cell lung cancer with EGFR mutations |
| Date of disclosure of the study information | 2016/10/19 |
| Last modified on | 2021/03/09 21:32:46 |
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Basic information
Public title
Resistant mechanisms to afatinib in non-small cell lung cancer with EGFR mutations
Acronym
Resistant mechanisms to afatinib
Scientific Title
Resistant mechanisms to afatinib in non-small cell lung cancer with EGFR mutations
Scientific Title:Acronym
Resistant mechanisms to afatinib
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the detection rate of T790M mutation in cfDNA from patients with resistance to afatinib
Basic objectives2
Others
Basic objectives -Others
search for biomarkars
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of T790M mutation in cfDNA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
afatinib
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)Histologically or cytologically confirmed non-small cell lung cancer patients
2)Patients with EGFR mutation
3)Patients treated with afatinib, or who have a planned treatment with afatinib
4)Blood sampling at resistance to afatinib
5)Patients who are considered to survive for more than 3 months
6)Written informed consent
7)Patients aged 20 years or older
Key exclusion criteria
1)Patients with active double or multifocal cancers
2)Patients whose lesions are hard to evaluate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kasahara |
Organization
kanazawa University Graduate School of Medical Sciences
Division name
Respiratory Medicine
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
076-265-2273
k-kasa@staff.kanazawa-u.ac.jp
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
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
076-265-2273
Homepage URL
hkimura3625@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Respiratory Medicine, Kanazawa University Hospital
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
Human Genome/Gene Analysis Research Ethics Committee of Kanazawa University
Address
Takara-machi 13-1, Kanazawa city
Tel
076-265-2110
rinri@adm.kanazawa-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
| 2016 | Year | 10 | Month | 19 | 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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028172
| 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 |
