UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010987 |
|---|---|
| Receipt number | R000012859 |
| Scientific Title | Indication criteria for endoscopic resection of early stage duodenal cancers: A retrospective multicenter study. |
| Date of disclosure of the study information | 2013/06/20 |
| Last modified on | 2024/12/25 17:01:14 |
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Basic information
Public title
Indication criteria for endoscopic resection of early stage duodenal cancers: A retrospective multicenter study.
Acronym
Indication criteria for endoscopic resection of primary duodenal cancer
Scientific Title
Indication criteria for endoscopic resection of early stage duodenal cancers: A retrospective multicenter study.
Scientific Title:Acronym
Indication criteria for endoscopic resection of primary duodenal cancer
Region
| Japan |
Condition
Condition
Early stage duodenal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish of indication and curative resection criteria for endoscopic resection of primary duodenal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk of lymph node metasitasis of primary duodenal cancer
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
- Early stage duodenal cancers were resected endoscopically or surgically.
Key exclusion criteria
cancer extension of duodenal papilla
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Uraoka |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3437
turaoka@a3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Uraoka |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3437
Homepage URL
turaoka@a3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for cancer research from the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Early Stage Duodenal Cancer Study Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 06 | Month | 20 | 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
| 2012 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2013 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012859
