UMIN-CTR Clinical Trial

Basic information
Public title	Study for genetic susceptibility to pancreatic cancer
Acronym	Study for genetic susceptibility to pancreatic cancer
Scientific Title	Study for genetic susceptibility to pancreatic cancer
Scientific Title:Acronym	Study for genetic susceptibility to pancreatic cancer
Region	Japan North America

Condition
Condition	pancreatic cancer
Classification by specialty	Gastroenterology Laboratory medicine Adult
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to identify putative susceptibility gene(s) and the risk of developing pancreatic cancer in Japanese population.
Basic objectives2	Others
Basic objectives -Others	To evaluate pattern of mutation, gene expression and epigenetic alterations unique to young onset (and other subsets of) pancreatic cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Whole-exome sequencing using genomic DNA isolated from saliva, blood and the tissue
Key secondary outcomes	Histopathological analysis and somatic mutation, gene expression and methylation analysis using the resected specimens

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	50 years-old >
Gender	Male and Female
Key inclusion criteria	For saliva and blood collection: Patients and volunteers who have given written informed consent Pancreatic cancer group: 1.Age between 20 and 49 2.Cases with histologically confirmed pancreatic ductal adenocarcinoma Control group: 1.Age older than 80 2.Healthy volunteers who have no the medical history of cancers and pre-malignant neoplasms. For tumor tissue collection: 1.Age older than 20 2.Cases with histologically confirmed pancreatic ductal adenocarcinoma 3.Available surgically resected tissue (formalin fixed paraffin embedded block) from pancreatic cancer
Key exclusion criteria	Cases with neuroendocrine tumor
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Yusuke Middle name Last name Mizukami
Organization	Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Division name	Division of Cancer Research
Zip code	065-0033
Address	14-3-1 Kita 33-jo Higashi, Higashi-ku, Sapporo, Hokkaido
TEL	011-722-1110
Email	ymizu_ccbr@tohtoku.jp

Public contact
1st name of contact person	1st name Yusuke Middle name Last name Mizukami
Organization	Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Division name	Division of Cancer Research
Zip code	065-0033
Address	14-3-1 Kita 33-jo Higashi, Higashi-ku, Sapporo, Hokkaido
TEL	011-722-1110
Homepage URL
Email	ymizu_ccbr@tohtoku.jp

Sponsor
Institute	Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan, USA

Other related organizations
Co-sponsor	Shonan Kamakura General Hospital Chiba Tokushukai Hospital Teine Keijinkai Hospital Shibetsu City Hospital Chiba-Nishi General Hospital Uji Tokushukai Medical Center Massachusetts General Hospital Asahikawa Medical University
Name of secondary funder(s)	American College of Gastroenterology Self funding

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

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	医療法人 徳洲会 札幌東徳洲会病院付属臨床研究センター

Other administrative information
Date of disclosure of the study information	2015 Year 04 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	Completed
Date of protocol fixation	2014 Year 10 Month 02 Day
Date of IRB	2014 Year 10 Month 02 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2018 Year 03 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	2015 Year 03 Month 31 Day
Last modified on	2019 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019512