UMIN-CTR Clinical Trial

Basic information
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
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
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

Assessment
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

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 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

Research contact person
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

Public contact
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

Sponsor
Institute	North East Japan Study Group (NEJSG)
Institute
Department

Funding Source
Organization	North East Japan Study Group (NEJSG)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 11 Day

Related information
URL releasing protocol	doi: 10.1371/journal.pone.0176525. PMID: 28448556; PMCID: PMC5
Publication of results	Published

Result
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

Progress
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

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.

Management information
Registered date	2014 Year 11 Month 11 Day
Last modified on	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018203