UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061355 |
|---|---|
| Receipt number | R000070200 |
| Scientific Title | Comparative Study of Specimen Adequacy Between Primary and Metastatic Lesions in Endoscopic Ultrasound-Guided Fine-Needle Biopsy for Pancreatic Masses Aimed at Comprehensive Genomic Profiling |
| Date of disclosure of the study information | 2026/04/22 |
| Last modified on | 2026/04/22 19:17:42 |
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Basic information
Public title
Comparative Study of Specimen Adequacy Between Primary and Metastatic Lesions in Endoscopic Ultrasound-Guided Fine-Needle biopsy for Pancreatic Masses Aimed at Comprehensive Genomic Profiling
Acronym
PANC-EUS-FNB Adequacy Study
Scientific Title
Comparative Study of Specimen Adequacy Between Primary and Metastatic Lesions in Endoscopic Ultrasound-Guided Fine-Needle Biopsy for Pancreatic Masses Aimed at Comprehensive Genomic Profiling
Scientific Title:Acronym
PANC-EUS-FNB Adequacy Study
Region
| Japan |
Condition
Condition
pancreatic lesions
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In patients with pancreatic lesions, this study aims to determine the optimal target for EUS-FNB when comprehensive genomic profiling is planned by comparing the success rate of meeting CGP requirements between primary lesion and metastatic lesion specimens obtained during the same EUS-FNB session.
Basic objectives2
Others
Basic objectives -Others
Nucleic acid quantity,Tumor fraction,Section surface area,Core tissue length,Histology score,Technical success rate,Procedure related adverse events,Success rate of comprehensive genomic profiling
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of specimens suitable for comprehensive genomic profiling will be compared between primary lesion specimens and metastatic lesion specimens.
Key secondary outcomes
Nucleic acid quantity,Tumor fraction,Section surface area,Core tissue length,Histology score,Technical success rate,Procedure related adverse events,Success rate of comprehensive genomic profiling
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit the study institution between the date of approval by the head of the institution and June 30, 2028
Patients with pancreatic mass lesions who have both primary and metastatic lesions amenable to EUS-FNB and are scheduled to undergo comprehensive genomic profiling
Patients from whom written informed consent can be obtained directly based on their own free will
Patients aged 18 years or older at the time of consent
Key exclusion criteria
Patients with a performance status of 3-4
Patients with a bleeding tendency or a platelet count <50000
Patients receiving two or more antithrombotic agents
Patients in whom no safe puncture route is available due to inability to visualize the lesion by EUS or due to intervening vessels
Pregnant women
Patients from whom written informed consent could not be obtained based on their own free will after receiving a full explanation of the study
Patients deemed inappropriate for participation by the principal investigator or sub-investigators for any other reason
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama university hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama
TEL
086-235-7219
pmug1j9r@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | FUJII |
Organization
Okayama university hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama
TEL
086-235-7219
Homepage URL
pmug1j9r@okayama-u.ac.jp
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
Funding Source
Organization
Okayama university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Clinical Research Review Committee, Medical Division
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama
Tel
086-223-7151
none
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
| 2026 | Year | 04 | Month | 22 | 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
| 2025 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070200
