UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042176 |
|---|---|
| Receipt number | R000048136 |
| Scientific Title | Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020) |
| Date of disclosure of the study information | 2020/10/19 |
| Last modified on | 2020/10/19 22:58:44 |
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Basic information
Public title
Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020)
Acronym
Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020)
Scientific Title
Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020)
Scientific Title:Acronym
Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020)
Region
| Japan |
Condition
Condition
amyloidosis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of amyloid PET imaging in severity assessment and therapy evaluation of amyloidosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intensity of tracer uptake in each organ.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Amyloid PET examination is perfomed when diagnosis of amyloidosis is made.
Patient who recieves treatment intervention requires sequential amyloid PET examinations after starting the treatment.
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
Any adult participant who is diagnosed as having amyloidosis.
Key exclusion criteria
Participant who doesn't agree to enroll the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Sekijima |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine (Neurology and Rheumatology)
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2673
sekijima@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Nagaaki |
| Middle name | |
| Last name | Katoh |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine (Neurology and Rheumatology)
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2673
Homepage URL
nagaaki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aizawa hospital
Name of secondary funder(s)
Alnylam corp.
IRB Contact (For public release)
Organization
Ethics Committee of Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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 | 10 | Month | 19 | 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
| 2020 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 19 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048136
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
