UMIN ID: UMIN000054664
Registered date:14/06/2024
Clinical Validation Study of Plasma-based RAS Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Colorectal cancer |
| Date of first enrollment | 2023/07/27 |
| Target sample size | 128 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of both KRAS and NRAS gene exon 2, 3 and 4 mutations between Test method and Reference method |
|---|---|
| Secondary Outcome | 1. Overall percent agreement (OPA) between Test method and Reference method 2. Positive predictive value (PPV) and negative predictive value (NPV) between Test method and Reference method 3. Codon-based concordance rate between Test method and Reference method in RAS mutation-positive cases 4. MAF correlation between Test method and Reference method in RAS mutation-positive cases |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | N/A |
Related Information
| Primary Sponsor | Sysmex Corporation |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Sysmex Corporation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masahiro Nishida |
| Address | 4-4-4 Takatsukadai, Nishi-ku, Kobe, 651-2271, Japan Japan 651-2271 |
| Telephone | 078-991-1911 |
| Nishida.Masahiro@sysmex.co.jp | |
| Affiliation | Sysmex Corporation Medical & Scientific Affairs |
| scientific contact | |
| Name | Takayuki Yoshino |
| Address | 6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan Japan |
| Telephone | 04-7133-1111 |
| tyoshino@east.ncc.go.jp | |
| Affiliation | National Cancer Center Hospital East Department of Gastroenterology and Gastrointestinal Oncology |