UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037916 |
|---|---|
| Receipt number | R000043218 |
| Scientific Title | A Korea-Japan multicenter joint project on Postoperative Adjuvant treatment for Ampulla of Vater cancer |
| Date of disclosure of the study information | 2019/09/05 |
| Last modified on | 2021/10/06 17:47:05 |
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Basic information
Public title
A Korea-Japan multicenter joint project
on Postoperative Adjuvant treatment for Ampulla of Vater cancer
Acronym
A Korea-Japan multicenter joint project
on Postoperative Adjuvant treatment for Ampulla of Vater cancer
Scientific Title
A Korea-Japan multicenter joint project
on Postoperative Adjuvant treatment for Ampulla of Vater cancer
Scientific Title:Acronym
A Korea-Japan multicenter joint project
on Postoperative Adjuvant treatment for Ampulla of Vater cancer
Region
| Japan | Asia(except Japan) |
Condition
Condition
Ampulla of Vater Cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate postoperative adjuvant treatment for ampulla of vater carcinoma
To compare the overall survival rates of ampulla of vater carcinoma according to
postoperative adjuvant therapy.
To compare the disease free survival rates of ampulla of vater carcinoma according to
postoperative adjuvant therapy.
The final goal of this study is to evaluate postoperative adjuvant treatment
for ampulla of vater cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3 year & 5 year overall survival
3 year & 5 year disease free survival
Key secondary outcomes
Recurrence patterns according to postoperative adjuvant treatment.
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent operation for ampulla of vater carcinoma and diagnosis
confirmed by histopathology between 2002. 1 and 2015. 12
Patients who underwent completed resection of tumor (included only R0 resection)
Key exclusion criteria
Patients without available data in the case report form (CRF)
Patients with combined cancer
30-day mortality case associated with operative complication
Patients with neoadjuvant treatment
Patients with R1/R2 resection of tumor
Target sample size
1090
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Endo |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
2360004
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
0457872650
endoit@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Yabushita |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
2360004
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
0457872650
Homepage URL
yabu23@yokohama-cu.ac.jp
Sponsor or person
Institute
Japanese Society of Hepato-Biliary-Pancreatic Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Korean Association of Hepato-Biliary-Pancreatic Surgery
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
3-9 Fukuura Kanazawaku Yokohama
Tel
0457872800
rinri@yokohama-cu.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
| 2019 | Year | 09 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 19 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort stud
Management information
Registered date
| 2019 | Year | 09 | Month | 03 | Day |
Last modified on
| 2021 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043218
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
