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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030615
Receipt No. R000034964
Scientific Title Cohort study of elderly with head and neck cancer
Date of disclosure of the study information 2017/12/28
Last modified on 2017/12/28

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Basic information
Public title Cohort study of elderly with head and neck cancer
Acronym elderly with head and neck cancer
Scientific Title Cohort study of elderly with head and neck cancer
Scientific Title:Acronym elderly with 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 examine treatment status and prognosis of elderly with head and neck cancers
Basic objectives2 Others
Basic objectives -Others To examine treatment status and prognosis of elderly with head and neck cancers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Completion rate of treatment
Overall survival rate
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
75 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Aquamous cell carcinoma of oral cavity, pharynx, larynx.
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Hirano
Organization Kyoto prefectural university of medicine
Division name Department of Otolaryngology Head and Neck Surgery
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL 075-251-5603
Email hirano@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Arai
Organization Kyoto prefectural university of medicine
Division name Department of Otolaryngology Head and Neck Surgery
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL 075-251-5603
Homepage URL
Email ararian@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization Kyoto prefectural university of medicine
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
Address
Tel
Email

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 12 Month 28 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
2017 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study to pursue elderly with head and neck cancers

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2017 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034964

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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