UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046480 |
|---|---|
| Receipt number | R000053031 |
| Scientific Title | Usability Study of Mobile App for Long-Term Follow-Up in Gene Therapy |
| Date of disclosure of the study information | 2021/12/26 |
| Last modified on | 2023/07/21 13:09:47 |
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Basic information
Public title
Usability Study of Mobile App for Long-Term Follow-Up in Gene Therapy
Acronym
Usability Study of Mobile App for Long-Term Follow-Up in Gene Therapy
Scientific Title
Usability Study of Mobile App for Long-Term Follow-Up in Gene Therapy
Scientific Title:Acronym
Usability Study of Mobile App for Long-Term Follow-Up in Gene Therapy
Region
| Japan |
Condition
Condition
Patients treated with onasemnogene abeparvovec
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating usability of a mobile app for pediatric patients after administration of gene therapy
Basic objectives2
Others
Basic objectives -Others
Consideration for follow-up methods after administration of gene therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survey for the usability of the mobile system
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with onasemnogene abeparvovec for SMA and the family member over 18 years old
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Nakakuni |
Organization
National Center for Child Health and Development
Division name
Gene and Cell Therapy Promotion Center
Zip code
157-8535
Address
2-10-1 Okura,Setagaya-ku,Tokyo
TEL
0334160181
nakakuni-m@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Nakakuni |
Organization
National Center for Child Health and Development
Division name
Gene and Cell Therapy Promotion Center
Zip code
157-8535
Address
2-10-1 Okura,Setagaya-ku,Tokyo
TEL
0334160181
Homepage URL
nakakuni-m@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura,Setagaya-ku,Tokyo
Tel
0334160181
nakakuni-m@ncchd.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-127
Org. issuing International ID_1
National Center for Child Health and Development
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 26 | 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
| 2021 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053031
