UMIN-CTR Clinical Trial

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

non-small-cell lung cancer

Classification by specialty

Pneumology

Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

YES

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare.

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

03

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

Registered date

2015

Year

03

Month

23

Day

Last modified on

2018

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019596