UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the detection of EGFR mutation using the high sensitive PCR method in lung cancer
Title of the study (Brief title)	Study on the detection of EGFR mutation
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	detection of EGFR mutation using plasma DNA in patients with lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detect the exon 19 deletion, the L858R mutation in EGFR exon 21 and T790M mutation in EGFR exon 20
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)advanced or recurrent NSCLC harboring common EGFR mutations (exon 19 deletions, and the L858R mutation in exon 21) confirmed by the Scorpion Amplified Refractory Mutation System (ARMS) method; (2) prior to the start of EGFR-TKI treatment or disease progression after EGFR-TKI treatment; (3) allowing the collection and genomic analysis of blood samples (20 mL); (4) able to provide written informed consent.
Key exclusion criteria	None
Target sample size	50

Research contact person
Name of lead principal investigator	Yasuhiro Koh
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	811-1 Kimiidera, Wakayama-shi, Wakayama
TEL	073-441-0619
Email	ykoh@wakayama-med.ac.jp

Public contact
Name of contact person	Hirotsugu Kenmotsu
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho. Sunto-gun, Shizuoka
TEL	0559895222
Homepage URL
Email	h.kenmotsu@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency Center for Revitalization Promotion.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	G&G SCIENCE CO., LTD
Name of secondary funｄer(s)

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	静岡県立静岡がんセンター

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 08 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	49 patients were enrolled and became the end of the study.

Management information
Registered date	2018 Year 07 Month 31 Day
Last modified on	2018 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038146