UMIN-CTR Clinical Trial

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