UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057154 |
|---|---|
| Receipt number | R000065320 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2026/05/27 19:56:05 |
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Basic information
Public title
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
Acronym
EUREKA study
Scientific Title
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
Scientific Title:Acronym
EUREKA study
Region
| Japan |
Condition
Condition
Pancreatic Invasive Ducatal Adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the clinical utility of the Idylla KRAS Mutation Assay using specimens obtained through Endoscopic Ultrasound Tissue Acquisition (EUS-TA) for invasive pancreatic ductal adenocarcinoma (PDAC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
- Turnaround time (TAT) of the Idylla KRAS Mutation Assay using cytology specimens.
- Success rate of the Idylla KRAS mutation assay
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key exclusion criteria
1. Patients deemed unsuitable for enrollment in this study by the physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Yatabe |
Organization
National Cancer Center Hospital
Division name
Department of Diagnostic Pathology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo, Tokyo, Japan
TEL
0335422511
yyatabe@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Okamoto |
Organization
Natonal Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo, Tokyo, Japan
TEL
0335422511
Homepage URL
kookamot@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1 Tsukiji, Chuo, Tokyo, Japan
Tel
0335422511
chuo-rinrishinsa@dl.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design
Single-center prospective observational study.
Study Methodology
Patients scheduled to undergo EUS-TA for pancreatic tumors will be enrolled. During diagnostic EUS-TA, if invasive pancreatic ductal adenocarcinoma (PDAC) is suspected based on rapid on-site evaluation (ROSE) performed by an on-site cytopathologist and if surplus ROSE specimens are available, these surplus specimens will be used for KRAS mutation testing with the Idylla KRAS Mutation Assay. The turnaround time (TAT) and the detection rate of KRAS mutations will be evaluated.
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065320
