UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021860 |
|---|---|
| Receipt number | R000025205 |
| Scientific Title | Exploratory study on detecting EGFR mutation including T790M with blood samples from patients with advanced non-small cell lung cancer after EGFR-TKI failure |
| Date of disclosure of the study information | 2016/04/11 |
| Last modified on | 2021/10/20 15:39:13 |
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Basic information
Public title
Exploratory study on detecting EGFR mutation including T790M with blood samples
from patients with advanced non-small cell lung cancer after EGFR-TKI failure
Acronym
EGFR mutation analysis including T790M for blood samples
Scientific Title
Exploratory study on detecting EGFR mutation including T790M with blood samples
from patients with advanced non-small cell lung cancer after EGFR-TKI failure
Scientific Title:Acronym
EGFR mutation analysis including T790M for blood samples
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer with EGFR mutation
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the procedure for detecting EGFR T790M mutation with blood samples
from patients refractory to EGFR-TKI as alternative method of re-biopsy from tissue samples
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rate of EGFR mutations including T790M in plasma
Key secondary outcomes
1) Concordance of EGFR mutation status between tissue samples and plasma
2) Correlation between EGFR mutation status and clinical background
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) Pathologically confirmation of non-small cell lung cancer
2) EGFR gene mutations are identified
3) Refractory to EGFR-TKI monotherapy or combination therapy
4) Written informed consent
Key exclusion criteria
Not applicable
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruyasu Murakami |
Organization
Shizuoka cancer center
Division name
Devision of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL
(+81)055-989-5222
ha.murakami@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Kawamura/ Murakami Haruyasu |
Organization
Shizuoka cancer center
Division name
Devision of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL
(+81)055-989-5222
Homepage URL
ta.kawamura@scchr.jp
Sponsor or person
Institute
Shizuoka cancer center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka cancer center
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
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 | 04 | Month | 11 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2016 | Year | 04 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025205
