UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057196 |
|---|---|
| Receipt number | R000065380 |
| Scientific Title | An attempt to evaluate the suitability of fine-needle aspiration biopsy specimens using electrical impedance characteristics |
| Date of disclosure of the study information | 2025/03/04 |
| Last modified on | 2025/11/08 11:39:33 |
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Basic information
Public title
An attempt to evaluate the suitability of fine-needle aspiration biopsy specimens using electrical impedance characteristics
Acronym
An attempt to evaluate the suitability of fine-needle aspiration biopsy specimens using electrical impedance characteristics
Scientific Title
An attempt to evaluate the suitability of fine-needle aspiration biopsy specimens using electrical impedance characteristics
Scientific Title:Acronym
An attempt to evaluate the suitability of fine-needle aspiration biopsy specimens using electrical impedance characteristics
Region
| Japan |
Condition
Condition
Pancreatic cancer, biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Since minute specimens are used for pathological diagnosis of pancreatic cancer, biliary tract cancer, etc., it is difficult to judge whether the specimen volume is sufficient at the time of tissue collection by endoscopic ultrasound fine needle aspiration biopsy or cholangioscopic biopsy. We will conduct a pilot study to see whether the specimen volume can be estimated non-invasively from the electrical impedance characteristics of the specimen, with the aim of developing future equipment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, positive predictive value, negative predictive value
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing endoscopic ultrasound-guided fine needle aspiration biopsy or fluoroscopic bile duct biopsy.
2) Patients aged 18 years or older at the time of consent.
3) Written informed consent has been obtained from the patient or their legal representative to participate in the study.
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | NOBUHIKO |
| Middle name | |
| Last name | FUKUBA |
Organization
Shimane University
Division name
Internal medicine II
Zip code
693-8501
Address
89-1,Enya-cho, Izumo, Shimane,Japan
TEL
0853-23-2111
nfukuba@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | NOBUHIKO |
| Middle name | |
| Last name | FUKUBA |
Organization
Shimane University
Division name
Internal medicine II
Zip code
693-8501
Address
89-1,Enya-cho, Izumo, Shimane,Japan
TEL
0853-23-2111
Homepage URL
nfukuba@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
NOBUHIKO FUKUBA
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1,Enya-cho, Izumo, Shimane,Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.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
| 2025 | Year | 03 | Month | 04 | 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 | 03 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2025 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065380
