UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015461 |
|---|---|
| Receipt number | R000017957 |
| Scientific Title | Feasibility study on detecting EGFR T790M mutation in cell free DNA from advanced non small cell lung cancer patients refractory to EGFR-TKI:WJOG8014LTR |
| Date of disclosure of the study information | 2014/10/17 |
| Last modified on | 2018/03/13 16:28:33 |
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Basic information
Public title
Feasibility study on detecting EGFR T790M mutation in cell free DNA
from advanced non small cell lung cancer patients refractory to EGFR-TKI:WJOG8014LTR
Acronym
Feasibility study on detecting EGFR T790M mutation in cell free DNA
from advanced non small cell lung cancer patients refractory to EGFR-TKI
Scientific Title
Feasibility study on detecting EGFR T790M mutation in cell free DNA
from advanced non small cell lung cancer patients refractory to EGFR-TKI:WJOG8014LTR
Scientific Title:Acronym
Feasibility study on detecting EGFR T790M mutation in cell free DNA
from advanced non small cell lung cancer patients refractory to EGFR-TKI
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer with EGFR mutation
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the procedure for detecting EGFR T790M mutation in cell free DNA from advanced non small cell lung cancer patients refractory to EGFR-TKI
Basic objectives2
Others
Basic objectives -Others
o evaluate the feasibility of detecting EGFR T790M mutation in cell free DNA from advanced non-small cell lung cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
feasibility of detecting EGFR T790M mutation in cell free DNA
from advanced non small cell lung cancer patients refractory to EGFR-TKI
Key secondary outcomes
detection rate of EGFR T790M mutations in plasma
concordance of EGFR mutation status between tissue sample and plasma
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) advanced non-small cell lung cancer harboring EGFR mutations
2) refractory to EGFR-TKI monotherapy or combination therapy
* accept patients receiving EGFR-TKI therapy beyond PD with or without local therapy such as radiation therapy for brain or bone metastasis
3) written informed consent obtained from the patient
Key exclusion criteria
Not applicable
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuto Nishio |
Organization
Kinki University
Division name
Faculty of Medicine, Dept. of Genome Biology
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511
TEL
072-366-0221
knishio@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
datacenter
Zip code
Address
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kinki University Faculty of Medicine, Dept. of Genome Biology
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
| 2014 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27542267
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
| 2014 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2014 | Year | 10 | Month | 17 | Day |
Last modified on
| 2018 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017957
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
