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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016984
Receipt No. R000019512
Scientific Title Study for genetic susceptibility to pancreatic cancer
Date of disclosure of the study information 2015/04/01
Last modified on 2019/05/15

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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
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
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

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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