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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
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 | 2020/12/02 |
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 |
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Condition | ||
Condition | cancer patients treated with immune checkpoint inhibitors | |
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | review, case report, animal study
languages other than English or Japanese |
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Target sample size |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | meta-analysis of published articles |
Management information | |||||||
Registered date |
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Last modified on |
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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 |