UMIN-CTR Clinical Trial

Basic information
Public title	Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer
Acronym	Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer
Scientific Title	Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer
Scientific Title:Acronym	Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer
Region	Japan

Condition
Condition	Non-Small-Cell Lung Cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We examine having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-original squamous epithelium non-small-cell lung cancer. In addition, We examine the effectiveness, safety of EGFR-TKI after the second treatment.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Having gene variation or not
Key secondary outcomes	Response rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Gene
Interventions/Control_1	Examination with bronchoscope and CT-guided needle biopsy
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.Histologically or cytologically proven non-small cell lung cancer 2.After EGFR gene variation was positive and EGFR-TKI was effective, a condition progressed
Key exclusion criteria	1.Serious medical complications 2.uncontrolled angina pectoris,myocardial infarction within 3 months, heart failure. 3.serious infectious diseases 4.Other clinical difficulties to this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsumi Nakatomi
Organization	Nagasaki University Hospital
Division name	Second Department of Internal Medicine
Zip code
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	095-819-7273
Email	dear_tm_1016_612@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Midori Shimada
Organization	Nagasaki University Hospital
Division name	Second Department of Internal Medicine
Zip code
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	095-819-7273
Homepage URL
Email	dear_tm_1016_612@yahoo.co.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	長崎大学病院(長崎県)、日本赤十字社長崎原爆病院(長崎県)、

Other administrative information
Date of disclosure of the study information	2015 Year 07 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	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
Date of IRB	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 12 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 01 Day
Last modified on	2019 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021021