UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043139 |
|---|---|
| Receipt number | R000049076 |
| Scientific Title | Prognostic significance of sarcopenia in patients treated with surgery or radiotherapy for head and neck cancer: A meta-analysis |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2022/04/16 22:32:20 |
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Basic information
Public title
Prognostic significance of sarcopenia in patients treated with surgery or radiotherapy for head and neck cancer: A meta-analysis
Acronym
effect of sarcopenia on head and neck cancer treatment
Scientific Title
Prognostic significance of sarcopenia in patients treated with surgery or radiotherapy for head and neck cancer: A meta-analysis
Scientific Title:Acronym
sarcopenia and head and neck cancer
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prognostic impact of sarcopenia on head and neck cancer
Basic objectives2
Others
Basic objectives -Others
effect on oncologic outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
disease-specific survival, disease-free survival
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
studies regarding the effect of sarcopenia on treatment outcomes in head and neck cancer
Treatment for head and neck cancer is either curative intent surgery or radiotherapy.
Key exclusion criteria
studies investigating nasopharyngeal carcinoma or thyroid cancer
hazard ratios are not available
non-human studies
reviews
conference abstracts
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | takenaka |
| Middle name | |
| Last name | yukinori |
Organization
Osaka university graduate school of medicine
Division name
department of otorhinolaryngology-head and neck surgery
Zip code
5650871
Address
2-2 yamadaoka, suita, osaka
TEL
+81-6-6879-3951
ytakenaka@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | takenaka |
| Middle name | |
| Last name | yukinori |
Organization
Osaka university graduate school of medicine
Division name
department of otorhinolaryngology-head and neck surgery
Zip code
5650871
Address
2-2 yamadaoka, suita, osaka
TEL
+81-6-6879-3951
Homepage URL
ytakenaka@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
osaka university
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
osaka university
Address
2-2 yamadaoka, suita, osaka
Tel
0662108290
rinri@hp-crc.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
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0259288
Publication of results
Unpublished
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0259288
Number of participants that the trial has enrolled
3233
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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Literature search is to be done on 2/1/2021.
Statistical analyses is to be done by 6/1/2021.
Management information
Registered date
| 2021 | Year | 01 | Month | 26 | 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=R000049076
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
