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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047823
Receipt No. R000050391
Scientific Title Multicenter clinical trial to search for factors related to cancer-related venous thromboembolism in Japanese patients.
Date of disclosure of the study information 2022/05/21
Last modified on 2022/05/21

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Basic information
Public title Exploratory research to establish the Khorana score in Japanese popuration
Acronym J-Khorana study
Scientific Title Multicenter clinical trial to search for factors related to cancer-related venous thromboembolism in Japanese patients.
Scientific Title:Acronym J-Khorana study
Region
Japan

Condition
Condition venous thromboembolism
Classification by specialty
Cardiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Thrombosis associated with malignant dieases (Cancer-VTE) is often found in clinical practice and it is often difficult to prioritize treatment. The Khorana score and Vienna score are known internationally as the cancer-VTE onset prediction evaluation score, but the BMI value of 35 kg / m2 or more is an index for scoring, and the genetic background is different. It is doubtful that if these scores are appropriate for the Japanese.
Basic objectives2 Others
Basic objectives -Others At present, there is no solid index worthy of the "Japanese version of Khorana score", and this time we have established the "Japanese version of Khorana score" by forming a tag at 19 cancer centers nationwide, and there is evidence from the cancer center. It is expected that it can be a precursor to Cancer-VTE by creating.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The onset of thromboembolism
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 All patients (outpatient or inpatient) newly diagnosed with malignant tumors at participating facilities during the three months from April 1st to June 30th, 2019.
Key exclusion criteria Those already known to have thrombosis.
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Sueta
Organization Kumamoto University
Division name Cardiovascular Medicine
Zip code 860-8556
Address 1-1-1 Honjo, Kumamoto City, Kumamoto Prefecture
TEL 096-373-5175
Email sueta-d@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Sueta
Organization Kumamoto University
Division name Cardiovascular Medicine
Zip code 860-8556
Address 1-1-1 Honjo, Kumamoto City, Kumamoto Prefecture
TEL 096-373-5175
Homepage URL
Email sueta-d@kumamoto-u.ac.jp

Sponsor
Institute a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan.
Institute
Department

Funding Source
Organization a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kumamoto University
Address 1-1-1 Honjo, Kumamoto City, Kumamoto Prefecture
Tel 096-373-5175
Email sueta-d@kumamoto-u.ac.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
2022 Year 05 Month 21 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 05 Month 21 Day
Date of IRB
2021 Year 07 Month 01 Day
Anticipated trial start date
2022 Year 05 Month 21 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2022 Year 05 Month 21 Day
Last modified on
2022 Year 05 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050391

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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