UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047823
Receipt number 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 18:25:04

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
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