UMIN-CTR Clinical Trial

Basic information
Public title	Venous thromboembolic events in pancreatic carcinoma patients
Acronym	NCCH-009
Scientific Title	Venous thromboembolic events in pancreatic carcinoma patients
Scientific Title:Acronym	NCCH-009
Region	Japan

Condition
Condition	Treatment naive pancreatic carcinoma patients
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	analyze the frequency of VTE and proposed as the diagnostic biomarker for pancreatic carcinoma patients
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	the likelihood of VTE
Key secondary outcomes	OS

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	Treatment naive pancreatic carcinoma patients
Key exclusion criteria	past history of VTE taking an anticoagulant
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shunsuke Middle name Last name Kondo
Organization	National Cancer Center Hosipital
Division name	Hepato-bilialy and pancreatic Oncology
Zip code	104-0045
Address	5-1-1, Tukiji, Chuo-ku, Tokyo
TEL	81335422511
Email	shkondo@ncc.go.jp

Public contact
Name of contact person	1st name Shunsuke Middle name Last name Kondo
Organization	National Cancer Center Hospital
Division name	Hepato-bilialy and pancreatic Oncology
Zip code	104-0045
Address	5-1-1, Tukiji, Chuo-ku, Toky
TEL	81335422511
Homepage URL
Email	shkondo@ncc.go.jp

Sponsor
Institute	National Cancer Center Hosipital Hepato-bilialy and pancreatic Oncology
Institute
Department

Funding Source
Organization	National Cancer Center Hosipital
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	NCCH
Address	5-1-1, Tukiji
Tel	03-3542-2511
Email	shkondo@ncc.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	国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/29682191
Number of participants that the trial has enrolled	103
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	Completed
Date of protocol fixation	2012 Year 11 Month 19 Day
Date of IRB	2012 Year 11 Month 19 Day
Anticipated trial start date	2012 Year 12 Month 04 Day
Last follow-up date	2019 Year 09 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NOT recruiting

Management information
Registered date	2012 Year 12 Month 04 Day
Last modified on	2019 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011128