UMIN-CTR Clinical Trial

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
Name of lead principal investigator	1st name Tomoya Middle name Last name Kawaguchi
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	545-8585
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
Name of contact person	1st name Kenji Middle name Last name Sawa
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	545-8585
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	Ethical Committee of Osaka City University Graduate School of Medicine
Address	1-2-7, Asahimachi, Abeno-ku, Osaka
Tel	06-6645-3456
Email	irb@med.osaka-cu.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	2017 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	74
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	Main results already published
Date of protocol fixation	2017 Year 03 Month 13 Day
Date of IRB	2016 Year 10 Month 27 Day
Anticipated trial start date	2017 Year 03 Month 13 Day
Last follow-up date	2018 Year 12 Month 31 Day
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	2019 Year 12 Month 09 Day

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