UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059162 |
|---|---|
| Receipt number | R000066146 |
| Scientific Title | A single-center prospective observational study evaluating the diagnostic yield of endoscopic ultrasound-guided tissue acquisition (EUS-TA) using BD CytoRich Red preservative fluid for pancreatic tumor |
| Date of disclosure of the study information | 2025/09/22 |
| Last modified on | 2025/09/22 21:00:35 |
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Basic information
Public title
A study on the effectiveness of a novel preservative fluid (CytoRich Red) for diagnosing pancreatic tumor using endoscopic ultrasound
Acronym
Pancreatic tumor EUS Study (CytoRich)
Scientific Title
A single-center prospective observational study evaluating the diagnostic yield of endoscopic ultrasound-guided tissue acquisition (EUS-TA) using BD CytoRich Red preservative fluid for pancreatic tumor
Scientific Title:Acronym
CytoRich Red EUS-TA Pancreatic Tumor Study
Region
| Japan |
Condition
Condition
pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To prospectively evaluate the diagnostic yield of endoscopic ultrasound-guided tissue acquisition (EUS-TA) using BD CytoRich Red preservative fluid for pancreatic tumor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, specificity, and accuracy of rapid on-site evaluation (ROSE)
Key secondary outcomes
Diagnostic yield of EUS-TA (Sensitivity, specificity, and accuracy based on histological and final cytological diagnoses)
Technical success rate of EUS-TA procedures
Incidence rate of adverse events (percentage of patients experiencing complications related to EUS-TA), details, and severity of adverse events
Proportion of samples successfully analyzed by next-generation sequencing (NGS) among specimens submitted for analysis
Proportion of tumor cells within collected samples
Detailed genomic alterations identified in successfully analyzed cases
Proportion of patients receiving targeted therapies matched to detected genomic alterations
Comparative evaluation of diagnostic yield and NGS success rate according to the type of needle used
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
| 150 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing endoscopic ultrasound-guided tissue acquisition (EUS-TA) for pancreatic tumors at our hospital between April 2025 and March 2028
Patients who provide written informed consent to participate in the study after receiving an adequate explanation and fully understanding the details
Key exclusion criteria
Patients who are medically ineligible for EUS-TA
Patients deemed inappropriate for participation in this study by the principal investigator or co-investigators
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Hara |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Gastroenterology
Zip code
2318682
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa, Japan
TEL
0456286100
hidenobu1005_0406@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hidenobu |
| Middle name | |
| Last name | Hara |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Gastroenterology
Zip code
2318682
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa, Japan
TEL
0456286100
Homepage URL
hidenobu1005_0406@yahoo.co.jp
Sponsor or person
Institute
Yokohama City Minato Red Cross Hospital
Institute
Department
Personal name
Hidenobu Hara
Funding Source
Organization
Self funding
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
Yokohama City Minato Red Cross Hospital
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa, Japan
Tel
0456286100
minato-kenkyu@yokohama.jrc.or.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 | 09 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center prospective observational study
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066146
