UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038665 |
|---|---|
| Receipt number | R000042708 |
| Scientific Title | Establishment of collecting method for minimum sample in the EUS-FNA diagnosis of pancreatic cnacer using the rapid diagnostic apparatus |
| Date of disclosure of the study information | 2019/11/24 |
| Last modified on | 2020/11/26 08:19:26 |
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Basic information
Public title
Establishment of collecting method for minimum sample in the EUS-FNA diagnosis of pancreatic cnacer using the rapid diagnostic apparatus
Acronym
Establishment of collecting method for minimum sample in the EUS-FNA diagnosis of pancreatic cnacer using the rapid diagnostic apparatus
Scientific Title
Establishment of collecting method for minimum sample in the EUS-FNA diagnosis of pancreatic cnacer using the rapid diagnostic apparatus
Scientific Title:Acronym
Establishment of collecting method for minimum sample in the EUS-FNA diagnosis of pancreatic cnacer using the rapid diagnostic apparatus
Region
| Japan |
Condition
Condition
Pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To diagnosis pancreatic cancer using the rapid diagnostic apparatus for EUS-FNA sample, we will establish better collecting method for minimum sample.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To diagnosis pancreatic cancer by the rapid diagnostic apparatus, we will establish the collecting method for more than 30mg/ml of the total protein concentrationin from EUS-FNA sample.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
EUS-FNA
Consecutive patients with suspicious pancreatic carcinoma who are referred for EUS-FNA sampling at Jikei University Hospital are prospectively recruited in this study between November 25, 2019 and June 30, 2021.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Presence of a suspicious pancreatic carcinoma which was detected by at least a single investigational modality such as computed tomography, magnetic resonance imaging or EUS, and patients with suspicious pancreatic carcinoma who were referred for EUS-FNA sampling at Jikei University Hospital.
2.Performance status; 0,1 and 2.
3.patients <=20 years old.
4.provision of written informed consent to
participate in the present study.
Key exclusion criteria
1.internal use of an antiplatelet or anticoagulant agent.
2.Patients with pregnancy and/or suspected.
3.Patients with inability to participate in this study owing to psychiatric disorder.
4.Patints who reject to participate in this study.
5.The situation of difficulty to start or or continue the EUS-FNA.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University School of Medicine
Division name
Departments of Endoscopy
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111(3181)
ccl09720@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University School of Medicine
Division name
Departments of Endoscopy
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111(3181)
Homepage URL
ccl09720@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
the Human Subjects Committee at the Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
03-3433-1111 ext.2134
rinri@jikei.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
| 2019 | Year | 11 | Month | 24 | 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
| 2019 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 23 | Day |
Last modified on
| 2020 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042708
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| Registered date | File name |
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