UMIN-CTR Clinical Trial

Basic information
Public title	Examination of CD109 expression in head and neck cancer
Acronym	Examination of CD109 expression in head and neck cancer
Scientific Title	Examination of CD109 expression in head and neck cancer
Scientific Title:Acronym	Examination of CD109 expression in 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 whether CD109 can be a biomarker in predicting the prognosis of head and neck cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between the presence or absence of CD109 expression and OS and PFS
Key secondary outcomes

Base
Study type	Observational

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	Among patients treated for head and neck cancer at Kitasato University Hospital between January 1, 2008 and December 31, 2013, biopsy was performed at Kitasato University Hospital Pathology Department and Otolaryngology / Head and Neck Surgery Patients with preserved formalin-fixed paraffin-embedded specimens of tissue and surgically resected tissue
Key exclusion criteria	None
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Taku Middle name Last name Yamashita
Organization	Kitasato University
Division name	Otorhinolaryngology / Head and Neck Surgery
Zip code	252-0373
Address	1-15-1 Kitazato Minami-ku Sagamihara Kanagawa Japan
TEL	042-778-8111
Email	tyamahns@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Shohei Middle name Last name Tsutsumi
Organization	Kitasato University
Division name	Otorhinolaryngology / Head and Neck Surgery
Zip code	252-0373
Address	Otorhinolaryngology / Head and Neck Surgery
TEL	042-778-8111
Homepage URL
Email	dm18020@st.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University School of Medicine / Hospital Ethics Committee
Address	1-15-1 Kitazato Minami-ku Sagamihara Kanagawa Japan
Tel	042-778-81118273
Email	rinri@med.kitasato-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 10 Month 01 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	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 19 Day
Date of IRB	2019 Year 01 Month 19 Day
Anticipated trial start date	2019 Year 01 Month 19 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a retrospective observational study. We will perform immunohistochemical staining using tissue specimens of patients stored at our hospital and collect information from medical records.

Management information
Registered date	2020 Year 10 Month 01 Day
Last modified on	2020 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047896

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.