UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048619
Receipt number R000055397
Scientific Title Cancer-associated thromboembolism in advanced pancreatic cancer: a multi-center prospective observational study
Date of disclosure of the study information 2022/08/10
Last modified on 2022/08/09 10:26:34

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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 or person

Institute

National Hospital Organization Kyushu Cancer Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055397


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name