UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016984 |
|---|---|
| Receipt number | 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 13:59:59 |
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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
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
ymizu_ccbr@tohtoku.jp
Sponsor or person
Institute
Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019512
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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