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Clinical Validation Study of Plasma-based BRAF Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer

Clinical Validation Study of Plasma-based BRAF Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer - Clinical Validation Study of Plasma-based BRAF Gene Mutation Testing using LS104R in Metastatic Colorectal Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000054666
Enrollment
113
Registered
2024-06-14
Start date
2023-06-09
Completion date
Unknown
Last updated
2026-09-14

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

Sponsors

Sysmex corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients with pathologically confirmed primary colorectal adenocarcinoma -Patients who are planned to be tested or already tested for BRAF testing using the MEBGEN RASKET-B kit as part of routine clinical practice, and the tissue sample is free of modifying radiation therapy or drug therapy -Patients aged 18 or older at the time of consent acquisition -Patients whose blood sample can be collected before surgery or initiation of drug therapy -Patients diagnosed with Stage IV or recurrent colorectal cancer by imaging findings -Patients with no prior drug therapy, or patients confirmed progressive disease (PD) based on imaging or clinical PD during drug therapy without having initiated subsequent treatment -Patient's written consent to participate in this study has been obtained

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of Test method compared to Reference method for the detection of BRAF V600E mutation.

Secondary

MeasureTime frame
-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.

Countries

Japan

Contacts

Public ContactMasahiro Nishida

Sysmex Corporation Medical & Scientific Affairs

Nishida.Masahiro@sysmex.co.jp078-991-1911

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026