UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025718 |
|---|---|
| Receipt number | R000029592 |
| Scientific Title | An obsevational study of EGFR mutation status by circulating tumor DNA and tissue during the osimertinib treatment in poor PS patients with T790M positive advanced NSCLC |
| Date of disclosure of the study information | 2017/01/18 |
| Last modified on | 2021/09/30 16:29:25 |
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Basic information
Public title
An obsevational study of EGFR mutation status by circulating tumor DNA and tissue during the osimertinib treatment in poor PS patients with T790M positive advanced NSCLC
Acronym
An observational study of EGFR muta
tion status during the osimertinib treatment in poor PS patients
Scientific Title
An obsevational study of EGFR mutation status by circulating tumor DNA and tissue during the osimertinib treatment in poor PS patients with T790M positive advanced NSCLC
Scientific Title:Acronym
An observational study of EGFR muta
tion status during the osimertinib treatment in poor PS patients
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clear the resistant mechanism of o
simertinib treatment for lung cancer h
arboring EGFR activating and T790M
mutations by periodical analysis of EG
FR mutations (activating, T790M, and
C797S) in circulating tumor DNA and tissue using an improved PNA-LNA PCR clamp method.
Basic objectives2
Others
Basic objectives -Others
To evaluate the percentage of the cas
es emerging C797S mutation in all os
eimertinib resistant patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence ratio of plasma C797
S mutations in all osimertinib resistant cases
Key secondary outcomes
Comparison of the therapeutic effect by the presence of C797S appearance at the time of all osimertinib resistant cases
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
1.The case registered with NEJ032B study
2.Written informed consent
Key exclusion criteria
An inappropriate case judged by
doctor in charge
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer center
Division name
Department of respiratory medicine
Zip code
Address
47-1 Nodayama, Medeshima-Shiote,Natori,Miyagi
TEL
022-384-3151
maemondo-ma693@miyagi-pho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kana Watanabe |
Organization
Miyagi Cancer center
Division name
Department of respiratory medicine
Zip code
Address
47-1 Nodayama, Medeshima-Shiote,Natori,Miyagi
TEL
022-384-3151
Homepage URL
watanabe-ka750@miyagi-pho.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
Funding Source
Organization
North East Japan Study Group (NEJSG)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Molecular Genetic Research Departm
ent, LSI Medience Corporation.
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
| 2017 | Year | 01 | Month | 18 | 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
| 2017 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was research accompanied with NEJ032B study. The results will be presented after presenation of rasult from NEJ032B.
The results of this study was accepted to
publish in JJCO in 2021.
Management information
Registered date
| 2017 | Year | 01 | Month | 17 | Day |
Last modified on
| 2021 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029592
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
