UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038762 |
|---|---|
| Receipt number | 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 19:51:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Obstetrics 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
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
mminami@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Institute of development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044186
