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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025718
Receipt No. 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 2017/01/17

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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
Email 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
Email watanabe-ka750@miyagi-pho.jp

Sponsor
Institute North East Japan Study Group (NEJSG)
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 18 Day
Last follow-up date
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.

Management information
Registered date
2017 Year 01 Month 17 Day
Last modified on
2017 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.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


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