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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038762
Receipt No. R000044186
Scientific Title Study of explorsion of the cause of cancer- and cancer therapy-associated thrombosis and development of its predicting markers
Date of disclosure of the study information 2020/06/01
Last modified on 2019/12/02

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Basic information
Public title The cancer-associated thrombosis-causing clinical characteristics study in Japan
Acronym CATCH-J study
Scientific Title Study of explorsion of the cause of cancer- and cancer therapy-associated thrombosis and development of its predicting markers
Scientific Title:Acronym CATCH-J study
Region
Japan

Condition
Condition Lung cancer, Gastrointestinal cancer, Pancreatic cancer,Genicological cancer, Symptomatic malignant myeloma
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Cardiology
Pneumology Hematology and clinical oncology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Obsterics and gynecology
Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the cause of cancer- and cancer therapy-associated thrombosis and to develop its predicting markers
Basic objectives2 Others
Basic objectives -Others To explore the cause of cancer- and cancer therapy-associated thrombosis and to develop its predicting markers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes thrombosis (at the time of registration and 6-month follow-up)
Key secondary outcomes thrombosis-related tests

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 Lung cancer, Gastrointestinal cancer, Pancreatic cancer,Genicological cancer, Symptomatic malignant myeloma
Key exclusion criteria 1) Subject's disagreement with written informed consent
2) Other conditions determined inappropriate by the responsible/sub doctor
Target sample size 2500

Research contact person
Name of lead principal investigator
1st name Hisanori
Middle name
Last name Horiuchi
Organization Institute of development, Aging and Cancer, Tohoku University
Division name Department of Molecular and Cellular Biology
Zip code 980-8575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8463
Email hisanori.horiuchi.e8@tohoku.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Minami
Organization Kyoto University Hospital
Division name Institute for Advancement of Clinical and Translational Science
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Kyoto 606-8507, Japan
TEL 075-751-4735
Homepage URL
Email mminami@kuhp.kyoto-u.ac.jp

Sponsor
Institute Institute of development, Aging and Cancer, Tohoku University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel 022-728-4105
Email med-kenkyo@grp.tohoku.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
2020 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information we are planning this multicenter prospective observational study, where total over 2,000 patients with lung cancer, uterine cancer, ovarian cancer, gastric cancer, colon cancer or multiple myeloma will be registered. The bloods at the enrollment and after 6 months are systematically examined for factors implicated in thrombosis formation.

Management information
Registered date
2019 Year 12 Month 02 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044186

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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