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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016879
Receipt No. R000019596
Scientific Title Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer.
Date of disclosure of the study information 2015/03/23
Last modified on 2018/09/25

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Basic information
Public title Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer.
Acronym Liquid Biopsy Study
Scientific Title Mutation analyses of plasma and tumor DNA in EGFR mutation-positive advanced non-small-cell lung cancer.
Scientific Title:Acronym 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
1st name
Middle name
Last name Isamu Okamoto
Organization Kyushu University Hospital
Division name Research Institute for Disease of the Chest / Center for Clinical and Translational Research
Zip code
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
1st name
Middle name
Last name Noriko Hidaka
Organization Graduate School of Medical Sciences, Kyushu University
Division name Research Institute for Disease of the Chest
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 23 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
2015 Year 02 Month 09 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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