UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010910 |
|---|---|
| Receipt number | 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 | 2020/12/14 22:41:51 |
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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
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
kobayashis@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
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
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
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
http://www.mtoyou.jp/jocs-2/
Number of participants that the trial has enrolled
276
Results
Incidence of CAT was 6.6% in pancreatic cancer cohort.
Plasma Tissue factor (TF) level was significant higher in patients with pancreatic cancer than that of healthy volunteers, even if patients did not show CAT.
Positive and negative predictive value was 23.1% and 94.6% using 100 pg/mL of plasma TF level as a cut-off, which were better than d-dimer or khorana score.
Results date posted
| 2020 | Year | 12 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 11 | Month | 04 | Day |
Baseline Characteristics
Total of 197 and 79 patients with pancreatic cancer and biliary tract cancer
Participant flow
Patients and helthy volunteers were obtained written informed consent, and they were prospectively registerd to this study. Then, plasma sample was collected.
Adverse events
Not applicable
Outcome measures
Incidence of CAT
Plasma TF level
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 27 | Day |
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
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012748
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