UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051111 |
|---|---|
| Receipt number | R000058292 |
| Scientific Title | An observational study of hereditary thrombophilia in Japan |
| Date of disclosure of the study information | 2023/05/25 |
| Last modified on | 2024/05/21 19:19:36 |
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Basic information
Public title
An observational study of hereditary thrombophilia in Japan
Acronym
JHTPR
Scientific Title
An observational study of hereditary thrombophilia in Japan
Scientific Title:Acronym
JHTPR
Region
| Japan |
Condition
Condition
Idiopathic thrombosis due to hereditary thrombophilia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence and clinical course of the idiopathic thrombosis due to hereditary thrombophilia
Basic objectives2
Others
Basic objectives -Others
To clarify the incidence and clinical course of the idiopathic thrombosis due to hereditary thrombophilia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of thrombosis or hemorrhage one and two year after registration
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with idiopathic thrombosis with hereditary thrombophilia after 1 Jan 2020.
Key exclusion criteria
Patients without hereditary thrombophilia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | KENJI |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Toka University Hachioji Hospital
Division name
Hematology and Oncology
Zip code
1920032
Address
1838 Ishikawa-machi Hachioji Tokyo
TEL
0426391111
kyokoyama@tokai.ac.jp
Public contact
Name of contact person
| 1st name | KENJI |
| Middle name | |
| Last name | YOKOYAMA |
Organization
Tokai University Hachioji Hospital
Division name
Hematology and Oncology
Zip code
1920032
Address
1838 Ishikawa-machi Hachioji Tokyo
TEL
0426391111
Homepage URL
kyokoyama@tokai.ac.jp
Sponsor or person
Institute
Tokai University Hachioji Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-58-1211
tokai-rec@tsc.u-tokai.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
東海大学医学部付属八王子病院（東京都）、慶應義塾大学（東京都）、金沢大学（石川県）、愛媛大学（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Thrombosis, Hemorrhage, Treatment
Management information
Registered date
| 2023 | Year | 05 | Month | 20 | Day |
Last modified on
| 2024 | 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=R000058292
