UMIN-CTR Clinical Trial

Basic information
Public title	A feasibility study of performance of a novel method for gene mutations in circulating tumor DNA
Acronym	Clinical performance of a novel method for gene mutations in circulating tumor DNA
Scientific Title	Clinical performance study of gene mutation test
Scientific Title:Acronym	Clinical performance study of gene mutation test
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Feasibility verification of EGFR T790M mutation detection using the Digital ICA system, a microfluidic device
Basic objectives2	Others
Basic objectives -Others	Feasibility verification of EGFR T790M mutation detection using the Digital ICA system, a microfluidic device
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	quantification of mutant allele and minimum detection limit
Key secondary outcomes	1) Calculation of backgroud noise 2) Seach for cut-off value

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) Cell free DNA samples collected in WJOG8014LTR study 2) Residual samples with informed consent that are stocked in WJOG-BBC (Bio-bank Center, West Japan Oncology Group,) 3) Ten samples (20 ng or more DNA) with EGFR T790M positive and other ten samples with EGFR T790M negative detected by the QX100 Droplet Digital PCR system (ddPCR)
Key exclusion criteria	none
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuto Middle name Last name Nishio
Organization	Kindai University Faculty of Medicine
Division name	Department of Genome Biology
Zip code	589-8511
Address	377-2 Ohno-higashi, Osaka-sayama
TEL	81-72-366-0221
Email	knishio@med.kindai.ac.jp

Public contact
Name of contact person	1st name Kazuko Middle name Last name Sakai
Organization	Kindai University Faculty of Medicine
Division name	Department of Genome Biology
Zip code	589-8511
Address	377-2 Ohno-higashi, Osaka-sayama
TEL	81-72-366-0221
Homepage URL
Email	kasakai@med.kindai.ac.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	Toppan Printing Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board, Kindai University Faculty of Medicine
Address	377-2 Ohno-higashi, Osaka-sayama
Tel	81-72-366-0221
Email	zizen@med.kindai.ac.jp

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	2019 Year 11 Month 25 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	10
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	2018 Year 11 Month 17 Day
Date of IRB	2019 Year 01 Month 28 Day
Anticipated trial start date	2019 Year 01 Month 28 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 11 Month 25 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044088