UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056038 |
|---|---|
| Receipt number | R000064041 |
| Scientific Title | Prospective observational study of sample processing method for rapid on-site evaluation of specimens obtained by Endoscopic ultrasound-guided fine needle aspiration |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2025/11/17 06:57:17 |
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Basic information
Public title
Prospective observational study of sample processing method for rapid on-site evaluation of specimens obtained by Endoscopic ultrasound-guided fine needle aspiration
Acronym
Prospective observational study of sample processing method for rapid on-site evaluation of specimens obtained by EUS-FNA
Scientific Title
Prospective observational study of sample processing method for rapid on-site evaluation of specimens obtained by Endoscopic ultrasound-guided fine needle aspiration
Scientific Title:Acronym
Prospective observational study of sample processing method for rapid on-site evaluation of specimens obtained by EUS-FNA
Region
| Japan |
Condition
Condition
Pancreatic disease, subepithelial lesion of gastrointestinal tract, swollen lymph nodes
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of the centrifugation method in EUS-FNA specimen processing
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of adequate specimen rates of squash and centrifugation methods in rapid cytology specimen processing
Key secondary outcomes
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
1. Patients who require EUS-FNA
2. Patients must be at least 18 years old
Key exclusion criteria
Patients deemed inappropriate for the study by the investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ishida |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterology and Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
TEL
+81-92-801-1011
y.ishida.cb@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ishida |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterology and Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
TEL
+81-92-801-1011
Homepage URL
y.ishida.cb@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Yusuke Ishida
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Fukuoka University
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
Tel
+81-92-801-1011
fumed-ethics@fukuoka-u.ac.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
| 2024 | Year | 11 | Month | 05 | 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
Suspended
Date of protocol fixation
| 2024 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
EUS-FNA is performed as usual, and rapid on-site evaluation (ROSE) of sample adequacy is performed on the obtained specimen. Samples for ROSE are processed by two methods as usual practice, the squash method and the centrifugation method, to evaluate the sample adequacy rate and to analyze the relationship with the clinical information. If ROSE cannot be performed due to insufficient specimen volume, ROSE is not performed. If a sufficient amount of specimen can be confirmed by addition EUS-FNA, ROSE is performed. The definition of an appropriate specimen is defined as a specimen with a sufficient quantity of cells qualitatively and quantitatively for cytological diagnosis, and the pathologist will make a decision at a later date as a routine examination. The pathologist's judgment is extracted from the medical record.
Management information
Registered date
| 2024 | Year | 11 | Month | 04 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064041
