Clinical evaluation study of newly developed Luminex-based all RAS mutation assay kit

Clinical evaluation study of newly developed Luminex-based all RAS mutation assay kit - Clinical evaluation study of newly developed Luminex-based all RAS mutation assay kit(RASKET (RAS KEy Testing) study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011784

Enrollment

300

Registered

2013-09-18

Start date

2013-09-19

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) Samples histologically confirmed primary colorectal adenocarcinoma 2) Sufficient quantity of formalin-fixed paraffin embedded (FFPE) samples is available 3) Age greater than or equal to 20 years old 4) Document-Signed informed consent from patients

Exclusion criteria

Exclusion criteria: 1) Patients judged as inappropriate for this study by investigator 2) Patients refusing a use of FFPE samples for the research

Design outcomes

Primary

Measure	Time frame
Concordance rate of both KRAS and NRAS gene exon 2, 3 and 4 mutations between standard genetic testings including sanger sequencing and an established in vitro diagnostic (IVD) kit for KRAS exon2, and a newly developed Luminex-based all RAS assay kit	—

Secondary

Measure	Time frame
- Concordance rate of KRAS gene exon 3 and 4 mutations and NRAS gene exon 2, 3 and 4 mutations between sanger sequencing method and a newly developed Luminex-based all RAS assay kit in patients with KRAS exon 2 gene mutation negative. - Comparison of genotypic variations concordance between sanger sequencing method and a newly developed Luminex-based RAS assay kit in both KRAS and NRAS gene exon 2, 3 and 4.	—

Measure

Time frame

- Concordance rate of KRAS gene exon 3 and 4 mutations and NRAS gene exon 2, 3 and 4 mutations between sanger sequencing method and a newly developed Luminex-based all RAS assay kit in patients with KRAS exon 2 gene mutation negative. - Comparison of genotypic variations concordance between sanger sequencing method and a newly developed Luminex-based RAS assay kit in both KRAS and NRAS gene exon 2, 3 and 4.

—

Countries

Japan

Contacts

Public ContactHirotaka Hara

Medical Biological Laboratories Co.,LTD. Intellectual Property and Clinical Development Department

hara.hirotaka@mbl.co.jp052-238-1901

Outcome results