UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042621 |
|---|---|
| Receipt number | R000048425 |
| Scientific Title | Predictive capability of sarcopenia in patients treated with immune checkpoint inhibitors. A meta-analysis |
| Date of disclosure of the study information | 2020/12/03 |
| Last modified on | 2022/04/16 22:16:27 |
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Basic information
Public title
Predictive capability of sarcopenia in patients treated with immune checkpoint inhibitors. A meta-analysis
Acronym
effect of sarcopenia on cancer immunotherapy
Scientific Title
Predictive capability of sarcopenia in patients treated with immune checkpoint inhibitors. A meta-analysis
Scientific Title:Acronym
effect of sarcopenia on cancer immunotherapy
Region
| Japan |
Condition
Condition
cancer patients treated with immune checkpoint inhibitors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate the predictive capability of sarcopenia in patients treated with immune checkpoint inhibitors
Basic objectives2
Others
Basic objectives -Others
effect of baseline sarcopenia on prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hazard ratio for progression free survival
hazard ratio for overall survival
odds ratio for objective response
odds ratio for disease control
odds ratio for toxicity
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
1,articles regarding cancer patients treated with immune checkpoint inhibitors
2,presence of sarcopenia was evaluated before the start of immunotherapy
3, hazard ratios or odds ratio for overall survival, progression-free survival, objective response rate, disease control rate, immune related toxicity are described or can be estimated.
Key exclusion criteria
review, case report, animal study
languages other than English or Japanese
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | yukinori |
| Middle name | |
| Last name | takenaka |
Organization
Kansai medical hospital
Division name
department of otolaryngology
Zip code
5600083
Address
1 Chome-1-7-2 Shinsenri Nishimachi, Toyonaka, Osaka 560-0083
TEL
+81668361199
ytakenaka@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | yukinori |
| Middle name | |
| Last name | takenaka |
Organization
Kansai medical hospital
Division name
department of otolaryngology
Zip code
5600083
Address
1 Chome-1-7-2 Shinsenri Nishimachi, Toyonaka, Osaka 560-0083
TEL
+81668361199
Homepage URL
ytakenaka@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Kansai medical hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kansai medical hospital
Address
1 Chome-1-7-2 Shinsenri Nishimachi, Toyonaka, Osaka 560-0083
Tel
+81668361199
ytakenaka@ent.med.osaka-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 | 12 | Month | 03 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/jcsm.12755
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jcsm.12755
Number of participants that the trial has enrolled
2501
Results
A total of 2501 patients from 26 studies were analysed.
Sarcopenia was observed in 44.7% of the patients and was significantly associated with poor survival.Poor radiological response to ICI therapy was observed in patients with sarcopenia.The occurrence of severe toxicity was not associated with sarcopenia.
Results date posted
| 2022 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with solid cancer treated with immune checkpoint inhibitors
Participant flow
Not applicable
Adverse events
Not applicable
Outcome measures
overall survival, progression-free survival
objective response rate, disease control rate
severe adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 05 | Month | 30 | Day |
Other
Other related information
meta-analysis of published articles
Management information
Registered date
| 2020 | Year | 12 | Month | 02 | Day |
Last modified on
| 2022 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048425
