UMIN-CTR Clinical Trial

Public title

Development of a comprehensive gene mutation testing system named Mutation Investigator using the Next-era Sequencer (MINtS)

Acronym

NEJ021A

Scientific Title

Development of a comprehensive gene mutation testing system named Mutation Investigator using the Next-era Sequencer (MINtS)

Scientific Title:Acronym

NEJ021A

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To detect multiple gene mutations by MINtS using clinical samples when making diagnosis

Basic objectives2

Others

Basic objectives -Others

a. Concordance of detecting rates of EGFR and ALK gene mutations between by MINtS and by previous methods covered by Japanese health insurance
b. Time of making RNA stock solution containing cancer cells after getting clinical samples

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Detecting rates of EGFR, ALK, KRAS, BRAF, RET, ROS1 gene mutations, BIM gene polymorphism, and others after adjusting pathology, age, sex, and smoking history

Key secondary outcomes

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1 Non small cell lung cancer patients on pathological examination
2 Pathological samples including cancer cells
3 Patients approved informed consent

Key exclusion criteria

no exclusion criteria

Target sample size

3000

Name of lead principal investigator

1st name	Koichi
Middle name
Last name	Hagiwara

Organization

Jichi Medical University

Division name

Respiratory Medicine

Zip code

330-0834

Address

1-847 Amanuma Omiya, Saitama City

TEL

048-647-2111

Email

hagiwark@saitama-med.ac.jp

Name of contact person

1st name	Kunihiko
Middle name
Last name	Kobayashi

Organization

Saitama Medical University International Medical Center

Division name

Department of Respiratory Medicine

Zip code

350-1298

Address

1397-1 Yamane Hidaka, Saitama 350-1298 Japan

TEL

042-984-4667

Homepage URL

Email

kobakuni@saitama-med.ac.jp

Institute

North East Japan Study Group (NEJSG)

Institute

Department

Personal name

Organization

North East Japan Study Group (NEJSG)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Saitama Medical University International Medical Center

Address

1397-1 Yamane Hidaka Saitama

Tel

042-984-4523

Email

chikens@saitama-med.ac.jp

Secondary IDs

YES

Study ID_1

NEJ021A

Org. issuing International ID_1

North East Japan Study Group

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

11

Month

11

Day

URL releasing protocol

doi: 10.1371/journal.pone.0176525. PMID: 28448556; PMCID: PMC5

Publication of results

Published

URL related to results and publications

PLoS One. 2017 Apr 27;12(4):e0176525.

Number of participants that the trial has enrolled

190

Results

We developed a next-generation sequencer (NGS)-based, multi-gene test named the MINtS for investigating driver mutations in both cytological specimens and snap-frozen tissue samples. The MINtS was used to investigate the EGFR, KRAS, BRAF genes from DNA, and the ERBB2, and the ALK, ROS1, and RET fusion genes from RNA. We focused on high specificity and sensitivity (more than 0.99) and even included samples with a cancer cell content of 1%.

Results date posted

2022

Year

11

Month

16

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Operated non-small cell lung cancer

Participant flow

After obtained informed consent from patients, histological samples are tested by MINtS.

Adverse events

None due to observational study

Outcome measures

The MINtS was used to investigate the EGFR, KRAS, BRAF genes from DNA, and the ERBB2, and the ALK, ROS1, and RET fusion genes from RNA. We focused on high specificity and sensitivity (more than 0.99) and even included samples with a cancer cell content of 1%.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

10

Month

08

Day

Date of IRB

2014

Year

10

Month

08

Day

Anticipated trial start date

2014

Year

11

Month

12

Day

Last follow-up date

2019

Year

08

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

At present, EGFR gene mutation and EML4-ALK fusion mutation for non-small cell lung cancer can be independently examined using health insurance in Japan. We have developed the comprehensive gene mutation testing system named Mutation Investigator using the Next-era Sequencer: MINtS, which enable to detect EGFR, ALK, KRAS, BRAF, RET, ROS1 gene mutations and BIM polymorphism using cytological samples at a time. In this study, feasibility and reliability of this method are investigated using clinical samples. In the future, we will add new driver mutations having their specific molecular targeted drugs and clinical importance.

Registered date

2014

Year

11

Month

11

Day

Last modified on

2022

Year

11

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018203