UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058380 |
|---|---|
| Receipt number | R000066743 |
| Scientific Title | Prevalence of sarcopenia and respiratory sarcopenia after chimeric antigen receptor gene-modified T cell therapy |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/07 08:57:30 |
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Basic information
Public title
Prevalence of sarcopenia and respiratory sarcopenia after chimeric antigen receptor gene-modified T cell therapy
Acronym
Prevalence of sarcopenia and respiratory sarcopenia after CAR-T cell therapy
Scientific Title
Prevalence of sarcopenia and respiratory sarcopenia after chimeric antigen receptor gene-modified T cell therapy
Scientific Title:Acronym
Prevalence of sarcopenia and respiratory sarcopenia after CAR-T cell therapy
Region
| Japan |
Condition
Condition
Malignant lymphoma, multiple myeloma
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of sarcopenia and respiratory sarcopenia after CAR-T cell therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle index before and after CAR-T cell therapy
Key secondary outcomes
Hand grip strength, walking speed, and respiratory muscle strength before and after CAR-T cell therapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo CAR-T cell therapy during hospitalization
Key exclusion criteria
Those with severe heart disease, lung disease, or brain or nervous system disorders; those with pacemakers; and those with other systemic conditions that are difficult to evaluate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuyoshi |
| Middle name | |
| Last name | Nishikado |
Organization
Hyogo Medical University Hospital
Division name
Rehabilitation Department
Zip code
6638501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798456111
nnishikado@gmail.com
Public contact
Name of contact person
| 1st name | Nobuyoshi |
| Middle name | |
| Last name | Nisikado |
Organization
Hyogo Medical University Hospital
Division name
Rehabilitation Department
Zip code
6638501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798456111
Homepage URL
nnishikado@gmail.com
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Gas Group Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1, Mukogawa, Nishinomiya, Hyogo
Tel
0798456111
nnishikado@gmail.com
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
| 2025 | Year | 07 | Month | 07 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066743
