UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023622 |
|---|---|
| Receipt number | R000027205 |
| Scientific Title | Molecular alterations and clinicopathological features in sporadic duodenal adenocarcinoma |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2019/08/16 16:06:37 |
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Basic information
Public title
Molecular alterations and clinicopathological features in sporadic duodenal adenocarcinoma
Acronym
Molecular alterations in duodenal adenocarcinoma
Scientific Title
Molecular alterations and clinicopathological features in sporadic duodenal adenocarcinoma
Scientific Title:Acronym
Molecular alterations in duodenal adenocarcinoma
Region
| Japan |
Condition
Condition
Primary extra-ampullary duodenal adenocarcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the molecular alterations in duodenal adenocarcinoma
Basic objectives2
Others
Basic objectives -Others
To clarify the association between clinicopathological features including mucin phenotype and molecular alterations in duodenal adenocarcinoma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Molecular analyses in duodenal adenocarcinoma
Key secondary outcomes
Association between clinicopathological features including mucin phenotype and molecular alterations in duodenal adenocarcinoma
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Primary extra-ampullary duodenal adenocarcinoma
Key exclusion criteria
1) Patients with a known familial cancer syndrome including familial adenomatous polyposis
2) Patients who have determined by
the physicians to have any reasons of unqualified
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Miwa |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya
TEL
0798-45-6665
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Jiro |
| Middle name | |
| Last name | Watari |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya
TEL
0798-45-6662
Homepage URL
watarij@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine,
Division of Gastroenterology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aichi Cancer Center Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya
Tel
0166-45-6662
watarij@hyo-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
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
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
No special instruction
Management information
Registered date
| 2016 | Year | 08 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027205
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/08/16 | 多施設共同特定臨床研究に対する補助事業研究計画書 Ver.8.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/08/16 | Watari_et_al-2019-Scientific_Reports.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/08/16 | Supplementary Figures and Tables.docx |
