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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034264
Receipt No. 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 2018/09/25

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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
Middle name
Last name Hiroshi Kawakami
Organization University of Miyazaki
Division name Department of Gastroenterology and Hepatology, Faculty of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miyazaki 889-9602, Japan
TEL 0985859797
Email hiropon@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tesshin Ban
Organization University of Miyazaki
Division name Department of Gastroenterology and Hepatology, Faculty of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miyazaki 889-9602, Japan
TEL 0985859797
Homepage URL
Email venzosan0204@gmail.com

Sponsor
Institute University of Miyazaki, Department of Gastroenterology and Hepatology, Faculty of Medicine
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 18 Day
Last follow-up date
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
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039065

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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