Clinical evaluation study of newly developed microsatellite instability test kit

Clinical evaluation study of newly developed microsatellite instability test kit - GI-SCREEN-CRC-MSI substudy 01

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024144

Enrollment

300

Registered

2016-09-23

Start date

2016-11-14

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

Advanced / recurrent colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients registered in GI-SCREEN CRC-MSI (UMIN000020437) and meet the following criteria; 1) Patients who agreed to the secondary usage of specimen when they agreed to GI-SCREEN CRC-MSI, and did not revoked their agreements. 2) Patients whose MSI status were decided by both tumor and normal samples in GI-SCREEN CRC-MSI 3) Sufficient quantity of DNA were extracted from patients' tumor sample for newly developed MSI test kit

Exclusion criteria

Exclusion criteria: 1) Patients judged as inappropriate for this study by investigator

Design outcomes

Primary

Measure	Time frame
To evaluate sensitivity (positive concordance rate) and specificity (negative concordance rate) between the standard method using both tumor and normal samples and the newly developed MSI test kit using only tumor samples	—

Countries

Japan

Contacts

Public ContactHideaki Bando

National Cancer Center Hospital East Department of Gastroenterology and Gastrointestinal Oncology

hbando@east.ncc.go.jp04-7133-1111

Outcome results