UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical validation study of RAKSET-B, a multiple detection kit for BRAF and RAS gene mutations in colorectal cancer
Title of the study (Brief title)	RAKSET-B study
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate whether a newly developed xMAP (Luminex) technology-based BRAF and RAS (KRAS and NRAS) gene mutation detection kit can detect BRAF and RAS gene mutations from FFPE (formalin-fixed paraffin embedded) samples in patients with advanced colorectal cancer.
Basic objectives2	Others
Basic objectives -Others	To compare the concordance between standard genetic testing including sanger sequencing, pyrosequencing and established in vitro diagnostic (IVD) kit for detecting RAS mutations, and a newly developed xMAP (Luminex)-based BRAF and RAS gene mutation detection kit
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	BRAF gene mutation* - Overall concordance rate, positive concordance rate, and negative concordance rate of BRAF gene mutations between standard genetic testing such as sanger sequencing and RASKET-B kit RAS gene mutation** - Overall concordance rate, positive concordance rate, and negative concordance rate of RAS gene mutations between MEBGEN RASKET KIT (an established in vitro diagnostic (IVD) kit for detecting RAS mutations) and RASKET-B kit *BRAF gene mutation codon 600 (p.V600E) **RAS gene mutation codon 12, 13, 59, 61, 117, 146
Key secondary outcomes	BRAF gene mutation - Consistency of BRAF gene mutation status between pyrosequencing and RASKET-B kit - Comparison of genotypic variations between sanger sequencing and RASKET-B kit RAS gene mutation - Consistency of RAS gene mutation status between sanger sequencing and RASKET-B kit - Comparison of genotypic variations between sanger sequencing and RASKET-B kit

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) Histologically confirmed primary colorectal adenocarcinoma 2) 20 years or older at the recruitment 3) Informed consent document signed by patients who then do not declare their intention of consent withdrawal, or performed the procedure for existing sample and information to be used in the trial, according to the plan approved by the IRB committee at each institution 4) Sufficient quantity of the DNA from FFPE samples is available
Key exclusion criteria	1) Inappropriate for this trial by investigators 2) Patients refusing a use of FFPE samples for the trial 3) The result of the RAS genetic test wasn't adequately obtained in the RASKET study
Target sample size	300

Research contact person
Name of lead principal investigator	Hiroya Taniguchi
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681 Japan
TEL	052-762-6111
Email	h.taniguchi@aichi-cc.jp

Public contact
Name of contact person	Yoshiyuki Fukushima
Organization	Medical Biological Laboratories Co.,LTD.
Division name	Regulatory Affairs and Clinical Development Department
Address	KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi, 460-0008 Japan
TEL	052-238-1901
Homepage URL
Email	fukushima.yoshiyuki@mbl.co.jp

Sponsor
Institute	Medical Biological Laboratories Co.,LTD.
Institute
Department

Funding Source
Organization	Medical Biological Laboratories Co.,LTD.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	愛知県がんセンター中央病院（愛知県） 大阪大学大学院医学系研究科（大阪府） 国立がん研究センター東病院（千葉県） 国立病院機構四国がんセンター（愛媛県） 埼玉県立がんセンター（埼玉県） 千葉県がんセンター（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 22 Day
Anticipated trial start date	2016 Year 07 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To evaluate whether a newly developed xMAP (Luminex) technology-based BRAF and RAS (KRAS and NRAS) gene mutation detection kit can detect BRAF and RAS gene mutations from FFPE (formalin-fixed paraffin embedded) samples in patients with advanced colorectal cancer. Informed consent document signed by patients who then do not declare their intention of consent withdrawal, or performed the procedure for existing sample and information to be used in the trial, according to the plan approved by the IRB committee at each institution. Sufficient quantity of the DNA from FFPE samples is available.

Management information
Registered date	2016 Year 06 Month 15 Day
Last modified on	2017 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026203