UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015798 |
|---|---|
| Receipt number | R000014784 |
| Scientific Title | Gene expression analysis of nonampullary sporadic duodenal tumors. |
| Date of disclosure of the study information | 2014/11/30 |
| Last modified on | 2023/06/07 11:58:40 |
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Basic information
Public title
Gene expression analysis of nonampullary sporadic duodenal tumors.
Acronym
Gene expression analysis of nonampullary sporadic duodenal tumors.
Scientific Title
Gene expression analysis of nonampullary sporadic duodenal tumors.
Scientific Title:Acronym
Gene expression analysis of nonampullary sporadic duodenal tumors.
Region
| Japan |
Condition
Condition
Patients with untreated nonampullary sporadic duodenal tumors.
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to identify genetic markers specific to duodenal tumors through gene expression analysis. Secondary objectives include analysis on the origin of nonampullary duodenal tumors, applications to pathological diagnosis, and application to chemotherapy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Gene expression analysis of nonampullary duodenal tumors through mRNA microarray.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Previously untreated nonampullary duodenal tumor with endoscopic, pathologic, radiologically assessment.
Key exclusion criteria
Ampullary duodenal tumor, past history of surgical resection of either the esophagus or stomach, familial polyposis, IBD, a final pathological diagnosis of advanced duodenal cancer.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobutake |
| Middle name | |
| Last name | Yamamichi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
1138655
Address
Bunkyo-ku Hongo 7-3-1
TEL
+819090180853
sakaguchi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Sakaguchi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
113-8655
Address
Bunkyo-ku Hongo 7-3-1
TEL
+819090180853
Homepage URL
sakaguchi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
Bunkyo-ku Hongou 7-3-1, Tokyo, JAPAN
Tel
+81338155411
sakaguchi-tky@umin.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
| 2014 | Year | 11 | Month | 30 | 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
11
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
| 2013 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
mRNA microarray assessment
Management information
Registered date
| 2014 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014784
