A Prospective Observational Study with EUS-Guided Tissue Acquisition Specimens for the Validation of Diagnostic Utility in the Rapid Evaluation of IdyllaTM KRAS Mutation Assay in Pancreatic Ductal Adenocarcinoma

A Prospective Observational Study with EUS-Guided Tissue Acquisition Specimens for the Validation of Diagnostic Utility in the Rapid Evaluation of IdyllaTM KRAS Mutation Assay in Pancreatic Ductal Adenocarcinoma - EUREKA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057154

Enrollment

Registered

2025-02-28

Start date

2025-02-17

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

Pancreatic Invasive Ducatal Adenocarcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients for whom EUS-TA is planned as part of routine clinical practice for the diagnosis of invasive pancreatic ductal adenocarcinoma. 2. Patients who have provided written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients deemed unsuitable for enrollment in this study by the physician.

Design outcomes

Primary

Measure	Time frame
- Turnaround time (TAT) of the Idylla KRAS Mutation Assay using cytology specimens. - Success rate of the Idylla KRAS mutation assay	—

Secondary

Measure	Time frame
1. Concordance between the KRAS mutation profile obtained by CGP and the Idylla KRAS mutation assay result 2. Detection rate of rare driver mutations or gene fusions identified by CGP among patients classified as KRAS wild-type by the Idylla KRAS mutation assay	—

Countries

Japan

Contacts

Public ContactKohei Okamoto

Natonal Cancer Center Hospital Department of Hepatobiliary and Pancreatic Oncology

kookamot@ncc.go.jp0335422511

Outcome results