UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047173 |
|---|---|
| Receipt number | R000053804 |
| Scientific Title | Utility of Endoscopic Ultrasound-Guided Tissue Acquisition for Precision Medicine -Multicenter Prospective Cohort Study- |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2022/03/14 19:25:08 |
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Basic information
Public title
Utility of Endoscopic Ultrasound-Guided Tissue Acquisition for Precision Medicine
-Multicenter Prospective Cohort Study-
Acronym
EUS-TA for Precision Medicine of PDAC
Scientific Title
Utility of Endoscopic Ultrasound-Guided Tissue Acquisition for Precision Medicine
-Multicenter Prospective Cohort Study-
Scientific Title:Acronym
EUS-TA for Precision Medicine of PDAC
Region
| Japan |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the success rate of multi gene panel using EUS-FNA samples for precision medicine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of multi gene panel using EUS-FNA specimens
Key secondary outcomes
Patient background factors and procedure factors involved in the success of multi gene panel using EUS-FNA specimens
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 20 years old and over
2. Cases that have been pathologically diagnosed as unresectable pancreatic malignant tumor
3. Cases scheduled to undergo cancer genome testing using EUS-FNA specimens
4. Patients who have received sufficient explanation about participation in the study, and after sufficient understanding, have obtained written consent by the patient's free will.
Key exclusion criteria
1. Cases who are thought to be ineligible for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | REIKO |
| Middle name | |
| Last name | ASHIDA |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-447-2300
rashida@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | REIKO |
| Middle name | |
| Last name | ASHIDA |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-447-2300
Homepage URL
ninai@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Medico's Hirata Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2022 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research method
1.Enroll the patient with consent in the study.
2.Register patient background factors and procedure factors when collecting EUS-FNA samples used for multi-gene panel testing.
3.Confirm with the pathologist whether the EUS-FNA sample is sufficient for the multi-gene panel test.
4.Submit the EUS-FNA sample to the multi-gene panel test.
5.Register the results of the multi-gene panel test and the results of the expert panel.
Observation/ evaluation
1.Survey items before entry of the study
Patient background factors and past history, age, gender, pancreatic cancer stage, treatment history
2.Survey items after entry of the study
Patient background factors at the time of sample collection, procedure factors, amount of collected DNA, results of oncogene panel test
Management information
Registered date
| 2022 | Year | 03 | Month | 14 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053804
