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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010910
Receipt No. R000012748
Scientific Title A prospective cohort study of thrombosis and tissue factor in patients with pancreas or biliary tract cancer
Date of disclosure of the study information 2013/06/10
Last modified on 2019/06/14

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Basic information
Public title A prospective cohort study of thrombosis and tissue factor in patients with pancreas or biliary tract cancer
Acronym Trombosis and tissue factor in pancreas or biliary tract cancer
Scientific Title A prospective cohort study of thrombosis and tissue factor in patients with pancreas or biliary tract cancer
Scientific Title:Acronym Trombosis and tissue factor in pancreas or biliary tract cancer
Region
Japan

Condition
Condition Patients with pancreas or biliary tract cancer who have not thrombosis
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clarifying whether pancreas and biliary tract cancer produce tissue factor and release the microparticle of it(Part I), and whether the microparticle relates to the thromboembolism in those patients(Part II)
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The concentration of tissue factor in resected specimen(Part I). The relationship between the microparticle level of tissue factor in the serum and the incidence of thromboembolism(Part II)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Part I; 1)clinically or pathologically diagnosed as pancreas or biliary tract cancer, 2)clinically diagnosed as resectable before the operation, 3)provided written informed consent, 4)without obstructive jaundice nor acute pancreatitis
Part II; 1)clinically or pathologically diagnosed as pancreas or biliary tract cancer, 2)clinically diagnosed as unresectable, 3)provided written informed consent, 4)without obstructive jaundice nor acute pancreatitis
Key exclusion criteria Part I; 1)have the medical history of thromboembolism whithin 5 years or have thrombosis at the time of inclusion, 2)inappropriate to this this study judged by the investigator
Part II; 1)have the medical history of thromboembolism whithin 5 years or have thrombosis at the time of inclusion, 2)allergy to the contrast enhancing media, 3)intake regularly anti-coagulant agent, 4)with obstrucive janudice or acute pancreatitis, 5)inappropriate to this this study judged by the investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Ohkawa
Organization Kanagawa Cancer Center
Division name Division of Hepatobiliary and Pancreas Oncology
Zip code 2410815
Address 2-3-2, Nakao, Asahi-ku, Yokohama City, Kanagawa Pref.
TEL 045-520-2222
Email s-ohk@kcch.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Kobayashi
Organization Kanagawa Cancer Center
Division name Division of Hepatobiliary and Pancreas Oncology
Zip code 2410815
Address 2-3-2, Nakao, Asahi-ku, Yokohama City, Kanagawa Pref.
TEL 045-391-5761
Homepage URL
Email kobayashis@kcch.jp

Sponsor
Institute Kanagawa Cancer Center
Institute
Department

Funding Source
Organization Kanagawa Cancer Center
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 Kanagawa Cancer Center
Address 2-3-2, Nakao, Asahi-ku, Yokohama City
Tel 0455202222
Email chiken-jimu@kcch.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 神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 10 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
2013 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 10 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study

Management information
Registered date
2013 Year 06 Month 09 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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