UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048406 |
|---|---|
| Receipt number | R000055177 |
| Scientific Title | Usefulness of endoscopic ultrasound-guided fine needle biopsy in tissue collection for precision medicine-multicenter retrospective cohort study- |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2022/07/19 23:41:54 |
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Basic information
Public title
Usefulness of endoscopic ultrasound-guided fine needle biopsy in tissue collection for precision medicine-multicenter retrospective cohort study-
Acronym
Usefulness of EUS-FNB in precision medicine
Scientific Title
Usefulness of endoscopic ultrasound-guided fine needle biopsy in tissue collection for precision medicine-multicenter retrospective cohort study-
Scientific Title:Acronym
Usefulness of EUS-FNB in precision medicine
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 cancer gene panel test using EUS-FNB samples in real world.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of cancer gene panel test using EUS-FNA specimens
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Cases that have been pathologically diagnosed as unresectable pancreatic cancer
2)Cases scheduled for cancer gene panel testing using EUS-FNA specimens
Key exclusion criteria
1) Cases refused to participate in this study
2) Cases that have been registered once in this study
Target sample size
300
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
6418509
Address
811-1 Kimiidera, Wakayama City
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
6418509
Address
811-1 Kimiidera, Wakayama City
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
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama City
Tel
073-447-2300/+81-73-447-2300
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 | 07 | Month | 20 | 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
| 2022 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055177
