UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045500 |
|---|---|
| Receipt number | R000051948 |
| Scientific Title | The exploratory study of the oncological implications by procedure during surgery for the primary hepato-biliary-pancreatic malignancy patients |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2024/09/18 09:27:47 |
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Basic information
Public title
The exploratory study of the oncological implications by procedure during surgery for the primary hepato-biliary-pancreatic malignancy patients
Acronym
The exploratory study of the oncological implications by procedure during surgery for the primary hepato-biliary-pancreatic malignancy patients
Scientific Title
The exploratory study of the oncological implications by procedure during surgery for the primary hepato-biliary-pancreatic malignancy patients
Scientific Title:Acronym
The exploratory study of the oncological implications by procedure during surgery for the primary hepato-biliary-pancreatic malignancy patients
Region
| Japan |
Condition
Condition
Hepato-biliary-pancreatic malignant tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate the oncological effects by procedure during surgery for the primary hepato-biliary-pancreatic malignancies by analyzing circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in portal and peripheral venous blood, the tumor microenvironment, and biological responses.
Basic objectives2
Others
Basic objectives -Others
An exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We analyze the CTCs and ctDNA in portal and peripheral venous blood during surgery and tumor tissue microenvironment in patients with the primary hepato-biliary-pancreatic malignancies.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients are planned to treat according to our protocol for the treatment of the primary hepato-biliary-pancreatic malignancies.
Key exclusion criteria
The patients follow our standard treatment protocol of the primary hepato-biliary-pancreatic malignancies.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kitahata |
Organization
Wakayama medical university
Division name
2nd department of surgery
Zip code
6418509
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
yuji-kh@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kitahata |
Organization
2nd department of surgery, Wakayama medical university
Division name
2nd department of surgery
Zip code
6418509
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
Homepage URL
Yuji-kh@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university
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
Wakayama medical university
Address
811-1 Kimiidera Wakayama, Japan
Tel
073-447-2300
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
| 2021 | Year | 10 | Month | 01 | 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
| 2021 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to analyze circulating tumor cells (CTCs) and cfDNA in portal and peripheral venous blood by procedure during surgery and to investigate their relationship to the tumor microenvironment of primary tumor tissues.
Management information
Registered date
| 2021 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051948
