UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009474 |
|---|---|
| Receipt number | R000011128 |
| Scientific Title | Venous thromboembolic events in pancreatic carcinoma patients |
| Date of disclosure of the study information | 2012/12/04 |
| Last modified on | 2019/09/05 09:42:12 |
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Basic information
Public title
Venous thromboembolic events in pancreatic carcinoma patients
Acronym
NCCH-009
Scientific Title
Venous thromboembolic events in pancreatic carcinoma patients
Scientific Title:Acronym
NCCH-009
Region
| Japan |
Condition
Condition
Treatment naive pancreatic carcinoma patients
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
analyze the frequency of VTE and proposed as the diagnostic biomarker for pancreatic carcinoma patients
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the likelihood of VTE
Key secondary outcomes
OS
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
Treatment naive pancreatic carcinoma patients
Key exclusion criteria
past history of VTE
taking an anticoagulant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kondo |
Organization
National Cancer Center Hosipital
Division name
Hepato-bilialy and pancreatic Oncology
Zip code
104-0045
Address
5-1-1, Tukiji, Chuo-ku, Tokyo
TEL
81335422511
shkondo@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kondo |
Organization
National Cancer Center Hospital
Division name
Hepato-bilialy and pancreatic Oncology
Zip code
104-0045
Address
5-1-1, Tukiji, Chuo-ku, Toky
TEL
81335422511
Homepage URL
shkondo@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hosipital
Hepato-bilialy and pancreatic Oncology
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hosipital
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
NCCH
Address
5-1-1, Tukiji
Tel
03-3542-2511
shkondo@ncc.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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29682191
Number of participants that the trial has enrolled
103
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 | 11 | Month | 19 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NOT recruiting
Management information
Registered date
| 2012 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011128
