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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040965
Receipt No. 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 2021/07/15

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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
Email 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
Email frkn505@gmail.com

Sponsor
Institute National Hospital Organization Kyushu Cancer Center
Institute
Department

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
Email nakagawa.kosuke.bc@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 Open public 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
2021 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046780

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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