UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044462 |
|---|---|
| Receipt number | R000050795 |
| Scientific Title | Development of cytological analysis of pancreatic cancer using homology technology |
| Date of disclosure of the study information | 2021/06/10 |
| Last modified on | 2023/09/03 11:49:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of cytological analysis of pancreatic cancer using homology technology
Acronym
Development of cytological analysis of pancreatic cancer using homology technology
Scientific Title
Development of cytological analysis of pancreatic cancer using homology technology
Scientific Title:Acronym
Development of cytological analysis of pancreatic cancer using homology technology
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Currently, medical image analysis research using artificial intelligence (AI) has been active. However, for randomly deformed lesions, systems using educational algorithms have major barriers to practical use, such as price, calculation time, and black boxing of algorithms. Especially in cytology, it is necessary to capture and analyze the random and three-dimensional distribution of lesions, which is extremely difficult to put into practical use.
Therefore, we will analyze the cytological image of pancreatic cancer using a new mathematical method, "homology profile method", and examine its effectiveness for cytology of pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity, specificity, and correct diagnosis rate of the homology profile method are calculated by comparing the analysis results of each sample by the homology profile method with the final pathological diagnosis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent EUS-FNA and underwent cytology
2) Patients whose background can be confirmed in medical records
Key exclusion criteria
Cases that the principal investigator / coordinator deems inappropriate for inclusion in the study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Yamada |
Organization
Mie University
Division name
Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
TEL
059(232)1111
reiko-t@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Yamada |
Organization
Mie University Hospital
Division name
Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
TEL
059(232)1111
Homepage URL
reiko-t@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
Tel
059(232)1111
reiko-t@med.mie-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
| 2021 | Year | 06 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items and contents to be collected
#Patient information (presence or absence of pancreatic cancer, final diagnosis, gender, age, stage for pancreatic cancer)
#Histopathological examination (microscopic image of cytological preparation)
Management information
Registered date
| 2021 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050795
