UMIN-CTR Clinical Trial

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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