UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052651 |
|---|---|
| Receipt number | R000060079 |
| Scientific Title | Identification of new susceptibility loci for pancreatic cancer in the Japanese population |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2025/02/08 10:53:43 |
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Basic information
Public title
Identification of new susceptibility loci for pancreatic cancer in the Japanese population
Acronym
Susceptibility loci for pancreatic cancer
Scientific Title
Identification of new susceptibility loci for pancreatic cancer in the Japanese population
Scientific Title:Acronym
Susceptibility loci for pancreatic cancer
Region
| Japan | North America |
Condition
Condition
Patients with pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Chest surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to identify novel germline genetic variants in patients who develop pancreatic cancer at younger than 50 years of age, among pancreatic cancers that often develop at an older age. In addition to pathological variants (SNPs) identified in previous studies, we will search for structural abnormalities such as large genomic deletions using new analytical techniques, long read sequencing and high-density genome mapping. This will make it possible to identify novel cancer susceptibility genes by searching for non-coding DNA regions. To gain a better understanding of the development of early-onset pancreatic cancer, we will examine both tumor tissue and non-coding regions for novel somatic mutations, including non-coding RNA and structural abnormalities. The knowledge gained from this research will be valuable in predicting the onset of juvenile pancreatic cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Search for germline mutations using peripheral blood mononuclear cells (all cases).
Key secondary outcomes
(1) Frequency of detection of multiple lesions including pancreatic cysts by MRI and other imaging modalities (all cases)
(2) Functional analysis of somatic mutations and drug responsiveness using primary cells in tumor tissues (in surgical cases where fresh tumor tissues can be secured prior to fixation)
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Japanese patients with pancreatic cancer diagnosed by imaging, blood findings, or histology at Asahikawa Medical University Hospital or the collaborating institution between the date of approval and March 2029.
(2) Patients must be at least 18 years old and less than 50 years old at the time of disease onset.
(3) Patients or healthy volunteers who have given written consent to participate in this study.
(4) Persons between the ages of 18 and 50 years old (regardless of gender) who visit Asahikawa Medical University Hospital or Sapporo Higashi Tokushukai Hospital.
(5) Persons who have given written consent to participate in this study.
Key exclusion criteria
<Patients with pancreatic cancer>
(1) Patients with histologically confirmed endocrine neoplasms
(2) Patients with serious underlying diseases or complications that would make it difficult to participate in the study.
(3) Patients who no longer meet the above selection criteria after enrollment or who are newly found to be in conflict with the exclusion criteria.
(4) Patients who are judged to be inappropriate as research subjects by the physician in charge.
<Volunteer>
None in particular
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Mizukami |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido
TEL
0166-68-2462
mizu@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Mizukami |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido
TEL
0166-68-2462
Homepage URL
mizu@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Yusuke Mizukami
Funding Source
Organization
Hitachi High-Tech Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa-Kosei General Hospital
Japanese Red Cross Asahikawa Hospital
Asahikawa City Hospital
Hokkaido University Hospital
Teine Keijinkai Hospital
Sapporo Higashi Tokushukai Hospital
IMS Sapporo Digestive Disease Center General Hospital
Engaru-Kosei General Hospital
Nayoro City Hospital
Shibetsu City Hospital
Shonan Kamakura General Hospital
Chibanishi General Hospital
Tottori University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido
Tel
0166-68-2297
sho-kenkyu@jimu.asahikawa-med.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
旭川医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2030 | 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
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060079
