UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040965 |
|---|---|
| Receipt number | R000046780 |
| Scientific Title | Prospective observational study of venous thromboembolism in advanced pancreatobiliary cancer |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/08/09 10:20:02 |
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Basic information
Public title
Prospective observational study of venous thromboembolism in advanced pancreatobiliary cancer
Acronym
Prospective observational study of venous thromboembolism in advanced pancreatobiliary cancer
Scientific Title
Prospective observational study of venous thromboembolism in advanced pancreatobiliary cancer
Scientific Title:Acronym
Prospective observational study of venous thromboembolism in advanced pancreatobiliary cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prognostic power and predictive factor of venous thromboembolism in advanced pancreatobiliary cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in overall survival between patients with and without venous thromboembolism
Key secondary outcomes
1. Difference in overall survival between patients with and without arterial thromboembolism
2. Predictive/risk factor of venous thromboembolism
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
2. Histologically confirmed unresectable adenocarcinoma of pancreas or biliary tract
Key exclusion criteria
1. Inappropriate cases judged by investigators
2. Patients with history of either medical or surgical treatment with pancreatic/biliary tract cancer
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Furukawa |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Hepato-biliary-pancreatology
Zip code
811-1395
Address
Notame 3-1-1,Minami-Ku, Fukuoka
TEL
092-541-3231
nhoebm@gmail.com
Public contact
Name of contact person
| 1st name | Lingaku |
| Middle name | |
| Last name | Lee |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Hepato-biliary-pancreatology
Zip code
811-1395
Address
Notame 3-1-1,Minami-Ku, Fukuoka
TEL
092-541-3231
Homepage URL
frkn505@gmail.com
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Cancer Center
Address
Notame 3-1-1,Minami-Ku, Fukuoka
Tel
092-541-3231
601-rinri@mail.hosp.go.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
| 2020 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2020 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046780
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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