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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027592
Receipt No. R000031611
Scientific Title Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Date of disclosure of the study information 2017/06/01
Last modified on 2017/06/01

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Basic information
Public title Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Acronym Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Scientific Title Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Scientific Title:Acronym Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Analyse the association between quantitative T790M analysis of pretreatment non-small cell lung cancer with EGFR mutation and efficacy of EGFR tyrosine kinase inhibitor
Perform mutation analysis using next generation sequencer
Compare T790M detection using Cobas V2.0 and degital droplet PCR
Basic objectives2 Others
Basic objectives -Others Compare quantitative analysis data of T790M using digital droplet PCR and pretreatment data of rebiopsy specimen
Analyse mutation using next generation sequencer of rebiopsy specimen
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between the quantity of T790M copies and progression free survival of EGFR tyrosine kinase inhibitor treatment
Key secondary outcomes The association between the quantity of T790M copies and response rate or overall survival
The association between efficacy of EGFR tyrosine kinase inhibitor mutations such as CTNNB1 and MET amplification
Compare T790M detection using Cobas V2.0 and degital droplet PCR

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 [Subject I]
1)Histologically and/or cytologically proven non-small cell lung cancer
2)Locally advanced or metastatic disease
3)EGFR mutation positive (deletion19 or L858R)
4)Start EGFR tyrosine kinase inhibitor treatment as first line therapy from August 2013 to July 2016
5)Have signed an informed consent document
[Subject II]
1)In subject I cases, patients who performed rebiopsy until Descember 2016
2)Have signed an informed consent
Key exclusion criteria none
Target sample size 52

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomoya Kawaguchi
Organization Osaka City University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL 06-6645-3793
Email kawaguchi.tomoya@med.osaka-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kenji Sawa
Organization Osaka City University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL 06-6645-3793
Homepage URL
Email sawa.kenji@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Graduate School of Medicine
Department of Respiratory Medicine
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2017 Year 06 Month 01 Day
Last modified on
2017 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031611

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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