UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Acronym	Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Scientific Title	Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Scientific Title:Acronym	Observational study on gene mutation and prognosis for patients with resectable pancreatic cancer
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Relationship between genetic alteration and prognosis in pancreatic cancer
Basic objectives2	Others
Basic objectives -Others	Search for factors related to gene mutation and prognosis of pancreatic cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between gene mutation (KRAS, TP53, CDKN2A, SMAD4) and prognosis in patients with surgically treated pancreatic cancer
Key secondary outcomes	The relationship between the following items and the relation between gene mutation or prognosis in pancreatic cancer patients who underwent surgical treatment 1)presence or absence of IPMN coexistence 2)desmoplastic change 3)diabetic status 4)smoking history 5)local immune responses(TIL:Tumor Infiltrating Lymphocyte, TLS:Tertiary Lymphoid Structure ) 6)systemic immune responses(ALC:Absolute Lymphocyte Counts, ANC:Absolute Neutrophil Counts, NLR:Neutrophil-to-Lymphocyte Ratio) The relationship between desmoplastic change and preoperative image 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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient who can obtain medical treatment content from medical record Patients who underwent surgical treatment for pancreatic cancer at Kobe university hospital between January 2008 and May 2017
Key exclusion criteria	Patients who did not participate in this research from published information Patients under 20 years of age
Target sample size	219

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsuhiro Masuda
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL	078-382-6305
Email	atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Atsuhiro Masuda
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Zip code
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL	078-382-6305
Homepage URL
Email	atmasuda@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university
Institute
Department

Funding Source
Organization	self funding
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 07 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	Open public recruiting
Date of protocol fixation	2018 Year 05 Month 25 Day
Date of IRB	2018 Year 06 Month 15 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We perform DNA analysis using specimens after resection of pancreatic cancer and retrospectively examine prognosis, patient background, blood examination data, imaging findings, treatments.

Management information
Registered date	2018 Year 06 Month 08 Day
Last modified on	2020 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037307