UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025112 |
|---|---|
| Receipt number | R000028860 |
| Scientific Title | Clinical efficacy of Liquid biopsy for acquired resistance to afatinib in EGFR positive NSCLC |
| Date of disclosure of the study information | 2016/12/05 |
| Last modified on | 2016/12/02 00:06:10 |
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Basic information
Public title
Clinical efficacy of Liquid biopsy for acquired resistance to afatinib in EGFR positive NSCLC
Acronym
Liquid biopsy for acquired resistance to afatinib
Scientific Title
Clinical efficacy of Liquid biopsy for acquired resistance to afatinib in EGFR positive NSCLC
Scientific Title:Acronym
Liquid biopsy for acquired resistance to afatinib
Region
| Japan |
Condition
Condition
EGFR mutation positive NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluate the frequency of T790M in patients who experienced acquired resistance to afatinib
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of T790M in patients who experienced acquired resistance to afatinib
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.EGFR mutation positive NSCLC
2.Patients who experienced progression during treatment with afatinib
3.Possible to submit blood sample
4.Presence of informed consent
Key exclusion criteria
Nothing
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Hida |
Organization
Aichi cancer center
Division name
Department of Thoracic Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya
TEL
052-762-6111
107974@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yoshida, Yuko Oya, Kentaro Ito |
Organization
Aichi cancer center, Matsusaka Municipal Hospital
Division name
Department of Thoracic Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya
TEL
052-762-6111
Homepage URL
yshima@aichi-cc.jp
Sponsor or person
Institute
Aichi cancer center
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
Address
Tel
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 | 12 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:
Prospective observational study
Management information
Registered date
| 2016 | Year | 12 | Month | 02 | Day |
Last modified on
| 2016 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028860
