UMIN ID: UMIN000054666
Registered date:14/06/2024
Clinical Validation Study of Plasma-based BRAF 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 | 2023/06/09 |
| Target sample size | 113 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Sensitivity and specificity of Test method compared to Reference method for the detection of BRAF V600E mutation. |
|---|---|
| Secondary Outcome | -Diagnostic accuracy of Test method compared to Reference method. -Positive predictive value (PPV) and negative predictive value (NPV) of Test method compared to Reference method. |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | -Patients judged ineligible to participate in the study -Patients previously enrolled in this study -Patients with history of multiple cancer or with a comorbid multiple cancer -Patients with synchronous or metachronous (within 5 years of disease-free interval) double cancer |
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, 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 |