UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040753 |
|---|---|
| Receipt number | R000045863 |
| Scientific Title | Observational study to reveal the risk of HTLV-1 infection in organ transplantation using HTLV-1 organ transplantation registry |
| Date of disclosure of the study information | 2020/06/22 |
| Last modified on | 2024/12/16 14:27:57 |
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Basic information
Public title
Observational study to reveal the risk of HTLV-1 infection in organ transplantation using HTLV-1 organ transplantation registry
Acronym
HTLV-1 organ transplantation registry
Scientific Title
Observational study to reveal the risk of HTLV-1 infection in organ transplantation using HTLV-1 organ transplantation registry
Scientific Title:Acronym
HTLV-1 organ transplantation registry
Region
| Japan |
Condition
Condition
Organ transplantation including HTLV-1-positive donors and/or recipients
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To reveal the risk of HTLV-1 infection in organ transplant recipients
Basic objectives2
Others
Basic objectives -Others
Cross-sectional study
Prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of HTLV-1-associated diseases after organ transplantation
Key secondary outcomes
Incidence of HTLV-1 infection in recipients of HTLV-1-positive organs
Patient survival
Graft survival
EQ-5D-5L score
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
Donors and recipients of organ transplantation in which the donor, the recipient, or both are HTLV-1-positive.
Key exclusion criteria
Patients considered unsuitable for participation in the study by the investigator.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Yamano |
Organization
St. Marianna University School of Medicine
Division name
Department of Neurology
Zip code
216-8512
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL
044-977-8111
yyamano@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Takao |
Organization
Secretariat of HTLV-1 organ transplantation registry
Division name
None
Zip code
216-8512
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL
044-977-8111
Homepage URL
htlv1-ishoku@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2020 | Year | 06 | Month | 22 | 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
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: cohort study
Management information
Registered date
| 2020 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045863
