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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040432
Receipt No. R000046142
Scientific Title A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/18

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Basic information
Public title A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Acronym A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Scientific Title A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Scientific Title:Acronym A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To predict the efficacy and therapeutic resistance of Osimertinib by the quantitative amount of EGFR active mutation and C797S.
To explore the possibility of PIK3CA, BRAF, beta-catenin, MET and HER2 as a chemoresistant marker of Osimertinib
using blood and biopsy sample.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint:To predict the efficacy of osimertinib according to quantitative amount ofEGFR mutation expression.
Secandary endpoint:To predict the efficacy of osimertinib according to quantitative amount of C797S.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathologically confirmation of non small cell lung cancer
2) EGFR gene mutation has been examined and administration of osimertinib is planned
3) ECOG-PS 0-2
4) Adequate organ functions
5) Expected survival over 12 weeks
6) Written informed consent
Key exclusion criteria 1)Active double cancer
2)Interstitial pneumonitis on chest CT
3)Active infectious disease
4) Not approbed for blood sampling
5) Plegnant woman
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Norimitsu
Middle name
Last name Kasahara
Organization Gunma University Hospital
Division name Innovative Medical Center
Zip code 371-8511
Address 3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8222
Email m14702016@gunma-u.ac.jp

Public contact
Name of contact person
1st name Norimitsu
Middle name
Last name Kasahara
Organization Gunma University Hospital
Division name Innovative Medical Center
Zip code 371-8511
Address 3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8222
Homepage URL
Email m14702016@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
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 Gunma Institutional Review Board
Address 3-39-15, Showa-machi, Maebashi, Gunma, Japan
Tel 027-220-7111
Email ciru_hitotaisho-irb@ml.gunma-u.ac.jp

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
2020 Year 06 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 06 Day
Date of IRB
2018 Year 09 Month 06 Day
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observation study

Management information
Registered date
2020 Year 05 Month 18 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046142

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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