UMIN-CTR Clinical Trial

Basic information
Public title	Cancer-associated thromboembolism in advanced pancreatic cancer: a multi-center prospective observational study
Acronym	Cancer-associated thromboembolism in advanced pancreatic cancer: a multi-center prospective observational study
Scientific Title	Cancer-associated thromboembolism in advanced pancreatic cancer: a multi-center prospective observational study
Scientific Title:Acronym	Cancer-associated thromboembolism in advanced pancreatic cancer: a multi-center prospective observational study
Region	Japan

Condition
Condition	Pancreatic cancer Cancer-associated thromboembolism
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the incidence of cancer-associated thromboembolism in patients with advanced pancreatic cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of cancer-associated thromboembolism at diagnosis and 3 months post diagnosis in patients with advanced pancreatic cancer
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically confirmed unresectable pancreatic cancer
Key exclusion criteria	1. Inappropriate cases judged by investigators 2. Patients with history of medical treatment with pancreatic cancer
Target sample size	400

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	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	九州がんセンター（福岡県）、九州大学病院（福岡県）、久留米大学病院（福岡県）、産業医科大学（福岡県）、福岡大学病院（福岡県）、福岡大学筑紫病院（福岡県）、北九州市立医療センター（福岡県）、九州医療センター（福岡県）、福岡東医療センター（福岡県）、済生会福岡総合病院（福岡県）、飯塚病院（福岡県）、九州中央病院（福岡県）、福岡赤十字病院（福岡県）、九州労災病院（福岡県）、戸畑共立病院（福岡県）、別府医療センター（大分県）、北九州総合病院（福岡県）、小倉記念病院（福岡県）、柳川病院（福岡県）、仲原病院（福岡県）

Other administrative information
Date of disclosure of the study information	2022 Year 08 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	Open public recruiting
Date of protocol fixation	2022 Year 06 Month 17 Day
Date of IRB	2022 Year 07 Month 05 Day
Anticipated trial start date	2022 Year 07 Month 06 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multi-center prospective observational study

Management information
Registered date	2022 Year 08 Month 08 Day
Last modified on	2022 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055397