UMIN-CTR Clinical Trial

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
Email	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
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	University of Miyazaki Hospital, Clinical Research Support Center
Address	5200 Kihara, Kiyotake, Miyazaki, Miyazaki
Tel	0985-85-9403
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039065