UMIN-CTR Clinical Trial

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
Email	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
Email	ysktakenaka@gmail.com

Sponsor
Institute	Osaka General Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031685