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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042621
Receipt No. 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 2021/06/06

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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
Email 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
Email ytakenaka@ent.med.osaka-u.ac.jp

Sponsor
Institute Kansai medical hospital
Institute
Department

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
Email 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
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 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
2021 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048425

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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