UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023349 |
|---|---|
| Receipt number | R000026905 |
| Scientific Title | A multicenter prospective study for the utility of a target sample check illuminator (TSCI), concerning the detection of target specimens in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples for pancreatic masses and lymph node tumors. |
| Date of disclosure of the study information | 2016/07/27 |
| Last modified on | 2022/08/01 17:14:41 |
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Basic information
Public title
A multicenter prospective study for the utility of a target sample check illuminator (TSCI), concerning the detection of target specimens in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples for pancreatic masses and lymph node tumors.
Acronym
A multicenter prospective study for the utility of a target sample check illuminator
Scientific Title
A multicenter prospective study for the utility of a target sample check illuminator (TSCI), concerning the detection of target specimens in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) samples for pancreatic masses and lymph node tumors.
Scientific Title:Acronym
A multicenter prospective study for the utility of a target sample check illuminator
Region
| Japan |
Condition
Condition
pancreatic masses and lymph node tumors.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will examine the advantage of introducing the use of a TSCI with EUS-FNA for pancreatic masses and lymph node tumors without using ROSE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rate for target specimens by viewing only.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We will perform endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for pancreatic masses and lymph node tumors.
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) Age of patients at start of the trial is 20 years or older
2) Patients with digestive malignant tumors with the need of pathological diagnosis before treatment
Key exclusion criteria
1) People who have taken chemotheraphy for malignant tumors within one month before the start of the trial.
2) Patients who have had other cancers
3) Patients who are taking anticoagulant or antithrombotic drugs
4) Women who are pregnant or are possibly pregnan
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Matsumoto |
Organization
Tottori University School of medicine
Division name
Division of Medicine and Clinical Science
Zip code
6838504
Address
36-1 Nishi-cho, Yonago 683-8504, Japan
TEL
0859-38-6527
ayano0620@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Matsumoto |
Organization
Tottori University School of medicine
Division name
Division of Medicine and Clinical Science
Zip code
6838504
Address
36-1 Nishi-cho, Yonago 683-8504, Japan
TEL
0859-38-6527
Homepage URL
ayano0620@hotmail.co.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University Hospital
Address
36-1 Nishi-cho, Yonago 683-8504, Japan
Tel
0859-38-6527
ayano0620@hotmail.co.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
| 2016 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
56
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026905
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
