UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer
Acronym	A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer
Scientific Title	A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer
Scientific Title:Acronym	A prospective study to evaluate the clinical significance of pancreatic elasticity measurement during chemotherapy for pancreatic cancer
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 correlation with treatment for pancreatic cancer by using elastography in US or EUS for measuring the stiffness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in pancreatic cancer stiffness
Key secondary outcomes	Characteristics Clinical findings Pathological findings

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)Patients over 20 years old 2)Cases in which US or EUS was performed and the final diagnosis was pancreatic cancer 3)Written informed consent
Key exclusion criteria	1)minors 2)Not written informed consent
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Ishikawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of gastroenterology
Zip code	466-8560
Address	65 tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2602
Email	ishitaku@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Masakatsu Middle name Last name Yoshikawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of gastroenterology
Zip code	466-8560
Address	65 tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2602
Homepage URL
Email	m-yoshi@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University Graduate School of Medicine
Address	65 tsurumai-cho, Showa-ku, Nagoya
Tel	052-744-2602
Email	m-yoshi@med.nagoya-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	2019 Year 12 Month 05 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	Preinitiation
Date of protocol fixation	2019 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 12 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	Prospective study

Management information
Registered date	2019 Year 12 Month 02 Day
Last modified on	2019 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044193