UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study on detecting EGFR T790M mutation in cell free DNA from advanced non small cell lung cancer patients refractory to EGFR-TKI:WJOG8014LTR
Title of the study (Brief title)	Feasibility study on detecting EGFR T790M mutation in cell free DNA from advanced non small cell lung cancer patients refractory to EGFR-TKI
Region	Japan

Condition
Condition	Advanced non-small cell lung cancer with EGFR mutation
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the procedure for detecting EGFR T790M mutation in cell free DNA from advanced non small cell lung cancer patients refractory to EGFR-TKI
Basic objectives2	Others
Basic objectives -Others	o evaluate the feasibility of detecting EGFR T790M mutation in cell free DNA from advanced non-small cell lung cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	feasibility of detecting EGFR T790M mutation in cell free DNA from advanced non small cell lung cancer patients refractory to EGFR-TKI
Key secondary outcomes	detection rate of EGFR T790M mutations in plasma concordance of EGFR mutation status between tissue sample and plasma correlation between EGFR mutation status and clinical background

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 non-small cell lung cancer harboring EGFR mutations 2) refractory to EGFR-TKI monotherapy or combination therapy * accept patients receiving EGFR-TKI therapy beyond PD with or without local therapy such as radiation therapy for brain or bone metastasis 3) written informed consent obtained from the patient
Key exclusion criteria	Not applicable
Target sample size	155

Research contact person
Name of lead principal investigator	Kazuto Nishio
Organization	Kinki University
Division name	Faculty of Medicine, Dept. of Genome Biology
Address	377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511
TEL	072-366-0221
Email	knishio@med.kindai.ac.jp

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	datacenter
Address	Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kinki University Faculty of Medicine, Dept. of Genome Biology
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 14 Day
Anticipated trial start date	2014 Year 11 Month 04 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	https://www.ncbi.nlm.nih.gov/pubmed/27542267
Results
Other related information	Nothing particular

Management information
Registered date	2014 Year 10 Month 17 Day
Last modified on	2018 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017957