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

Not Applicable

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000011784
• Lead Sponsor: Medical Biological Laboratories Co.,LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- 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.