Clinical validation study of RAKSET-B, a multiple detection kit for BRAF and RAS gene mutations in colorectal cancer

Clinical validation study of RAKSET-B, a multiple detection kit for BRAF and RAS gene mutations in colorectal cancer - RAKSET-B study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022742

Enrollment

300

Registered

2016-06-15

Start date

2016-07-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactYoshiyuki Fukushima

Medical Biological Laboratories Co.,LTD. Regulatory Affairs and Clinical Development Department

fukushima.yoshiyuki@mbl.co.jp052-238-1901

Outcome results