UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027656 |
|---|---|
| Receipt number | R000031685 |
| Scientific Title | thrombocytosis as a prognostic marker for head and neck cancer: a meta-analysis |
| Date of disclosure of the study information | 2017/06/10 |
| Last modified on | 2022/04/16 22:29:35 |
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Basic information
Public title
thrombocytosis as a prognostic marker for head and neck cancer: a meta-analysis
Acronym
thrombocytosis and head and neck cancer
Scientific Title
thrombocytosis as a prognostic marker for head and neck cancer: a meta-analysis
Scientific Title:Acronym
thrombocytosis and head and neck cancer
Region
| Japan |
Condition
Condition
head and neck squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to quantify the prognostic impact of platelet count and platelet-lymphocyte ratio in head and neck squamous cell carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival
Key secondary outcomes
disease-specific 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
(1) studies reporting the prognostic impact of pretreatment PC or PLR in peripheral blood in head and neck cancer, (2) studies where the hazard ratio (HR) and 95% confidence interval (CI) or p-value for overall survival (OS) and disease-specific survival (DSS) were available, (3) the histological type of the tumors was considered to be predominantly squamous cell carcinoma (SCC).
Key exclusion criteria
(1) nonhuman studies and those in languages other than English, (2) studies focusing on thyroid cancer or nasopharyngeal cancer, (3) studies focusing on salivary gland cancer or nasal and paranasal cancer where SCC and non-SCC were analyzed together.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Yukinori |
| Middle name | |
| Last name | Takenaka |
Organization
Osaka General Medical Center
Division name
otorhinolaryngology and head and neck surgery
Zip code
5588858
Address
3-1-56 Bandai Higashi, Sumiyoshi, Osaka
TEL
0666921201
ysktakenaka@gmail.com
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Takenaka |
Organization
Osaka General Medical Center
Division name
otorhinolaryngology and head and neck surgery
Zip code
5588858
Address
3-1-56 Bandai Higashi, Sumiyoshi, Osaka
TEL
0666921201
Homepage URL
ysktakenaka@gmail.com
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2017 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/hed.25366
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1002/hed.25366
Number of participants that the trial has enrolled
2327
Results
Elevated platelt count and platelet-to-lymphocyte ratio were associated with prognosis of patients with head and neck squamous cell carcinoma.
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 head and neck squamous cell carcinoma
Participant flow
Not applicable
Adverse events
Not applicable
Outcome measures
overall survival, disease specific survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a Meta-analysis of published studies regarding the association of PC and PLR with HNSCC in electronic databases (PubMed and Scopus)
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | 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=R000031685
