UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034264 |
|---|---|
| Receipt number | R000039065 |
| Scientific Title | Prospective observational study of the pancreatic cancer microenvironment in EUS-FNB specimen procured by Franseen needle and chemotherapy response |
| Date of disclosure of the study information | 2018/09/26 |
| Last modified on | 2021/03/29 11:48:43 |
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Basic information
Public title
Prospective observational study of the pancreatic cancer microenvironment in EUS-FNB specimen procured by Franseen needle and chemotherapy response
Acronym
The pancreatic cancer microenvironment in the EUS-FNB specimen and chemotherapy
Scientific Title
Prospective observational study of the pancreatic cancer microenvironment in EUS-FNB specimen procured by Franseen needle and chemotherapy response
Scientific Title:Acronym
The pancreatic cancer microenvironment in the EUS-FNB specimen and chemotherapy
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of the microenvironment in the pancreatic cancer specimen of EUS-FNB on the chemotherapy response
Basic objectives2
Others
Basic objectives -Others
To quantify the tumor vascularity, hardness using cross-sectional image, and to evaluate the effect on the chemotherapy response.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the factors in the microenvironment of the pancreatic cancer specimen procured by EUS-FNB influence on the chemotherapy response, PFS, RFS, OS
Key secondary outcomes
- Relation between the tumor vascularity, hardness and the chemotherapy response, PFS, RFS, OS.
- To identify the factors in the microenvironment of the tumor specimen influence on neoadjuvant chemotherapy.
- To compare the microenvironment between EUS-FNB and the surgically acquired specimen.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years<=.
2) Cross-sectional image consistent with pancreatic cancer.
3) Scheduled EUS-FNA.
4) Scheduled chemotherapy.
5) Written informed consent.
Key exclusion criteria
1) Iodine allergy, egg allergy.
2) Coagulopathy.
3) Unsuitable for EUS-FNB.
4) Not obtained written informed consent.
5) Others.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawakami |
Organization
University of Miyazaki
Division name
Department of Gastroenterology and Hepatology, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Miyazaki 889-9602, Japan
TEL
0985859797
hiropon@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tesshin |
| Middle name | |
| Last name | Ban |
Organization
University of Miyazaki
Division name
Department of Gastroenterology and Hepatology, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Miyazaki 889-9602, Japan
TEL
0985859797
Homepage URL
venzosan0204@gmail.com
Sponsor or person
Institute
University of Miyazaki, Department of Gastroenterology and Hepatology, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki, Department of Gastroenterology and Hepatology, Faculty of Medicine
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
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki, Miyazaki
Tel
0985-85-9403
igakubu_kenkyu@med.miyazaki-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
| 2018 | Year | 09 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 09 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039065
