UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer.
Title of the study (Brief title)	Liquid Biopsy Study
Region	Japan

Condition
Condition	non-small-cell lung cancer
Classification by specialty	Pneumology Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate clinical benefit of liquid biopsy by measuring a somatic cell mutation such as EGFR gene mutation from peripheral circulating free DNA (tumor-specific circulating cell-free DNA: cfDNA) derived from plasma and DNA derived from tumors collected before and after treatment with EGFR-tyrosine kinase inhibitor (EGFR-TKI) using digital PCR and next-generation sequencer in patients with EGFR gene mutation-positive non-small-cell lung cancer.
Basic objectives2	Others
Basic objectives -Others	Clinical benefit of liquid biopsy by measuring the somatic cell mutation such as EGFR gene mutation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of EGFR gene mutation from cfDNA collected before and after treatment with EGFR-TKI in patients with EGFR gene mutation- positive non-small-cell lung cancer.
Key secondary outcomes	Detection of a biomarker about EGFR-TKI tolerance. Coincidence ratio of detection of EGFR gene mutation between tissue samples and cfDNA. Association between the clinical background including a presence or absence of T790M gene mutation and the prognosis.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with EGFR gene mutation (exon 19 deletion, L858R, G719X, L861M, T790M, etc) -positive non-small-cell lung cancer determined with a histological diagnosis or cytodiagnosis. 2)Patients with treatment plan of EGFR-TKI alone or combination therapy including EGFR-TKI. In addition, plasma samples of patients before treatment are stored at -80 degrees Celsius even if after the start of treatment. 3)Patients with more than 20 years. 4)Patients providing written informed consent.
Key exclusion criteria	1) Patient with positive HBs antigen or HVC antibody. 2) Patient with definite positive HIV antibody (need not for examination). 3) Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	Isamu Okamoto
Organization	Kyushu University Hospital
Division name	Research Institute for Disease of the Chest / Center for Clinical and Translational Research
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-city, Fukuoka 812-8582, Japan
TEL	092-642-5378
Email	okamotoi@kokyu.med.kyushu-u.ac.jp

Public contact
Name of contact person	Noriko Hidaka
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Research Institute for Disease of the Chest
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-city, Fukuoka 812-8582, Japan
TEL	092-642-5378
Homepage URL
Email	noriko-f@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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	2015 Year 03 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 09 Day
Anticipated trial start date	2015 Year 02 Month 18 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 09 Month 18 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Peripheral blood (7ml, EDTA-2Na) is collected before treatment with EGFR-TKI (from -4 weeks to treatment start day) and at 12 weeks, at 24weeks, at 36 weeks, after every 12 weeks (the allowance day: 1 week) after treatment start and at disease progression (within 2 weeks after PD confirmation). The submission of tumor samples is not essential. However, the following samples are submitted to investigate the correlation between tumor sample and cfDNA about having T790M gene mutation or not, in the cases that one of the following samples (no limit at collection time) are stored before start of EGFR-TKI treatment, or a re-biopsy is carried out from the progression of disease during treatment with EGFR-TKI. /Six pieces of slide specimens which performed slicing to a 4-5 microns thickness of the paraffin embedded specimen. /One piece of prepared slide (Papanicolaou stain) used for a cytodiagnosis. /Twenty ml (10mLx2) of malignant pleural effusion was centrifuged (1400g for 10min at room temperature), and stored two pellets at -80 degrees Celsius after removal of a supernatant. The supernatant is not removed too much (leave around 1cm). /DNA extract (samples after EGFR gene mutation examination) /Cell block

Management information
Registered date	2015 Year 03 Month 23 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019596