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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032465
Receipt No. R000036178
Scientific Title The Head and Neck Cancer Registry in Japan
Date of disclosure of the study information 2018/05/07
Last modified on 2020/04/13

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Basic information
Public title The Head and Neck Cancer Registry in Japan
Acronym HNC Registry in Japan
Scientific Title The Head and Neck Cancer Registry in Japan
Scientific Title:Acronym HNC Registry in Japan
Region
Japan

Condition
Condition Head and Neck Cancer
Classification by specialty
Oto-rhino-laryngology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The evaluation and development of medical treatment for patients with head and neck cancer in Japan
Basic objectives2 Others
Basic objectives -Others Epidemiological investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical baseline data of the patients;the number of primary site, pathology, modality and prognosis
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 Registration is restricted to previously untreated malignant head and neck tumor cases which have patholigical confirmation.
The primary sites are oral cavity, larynx, nasopharynx, oropharynx, hypopharynx, nasal cavity, paranasal sinuses and major salivary glands.
The patients received initial medical treatment including best supportive care, and had been observed in participating institution.
Key exclusion criteria without pathological confirmation,
patients who want to know second opinion or other treatment option.
Target sample size 100000

Research contact person
Name of lead principal investigator
1st name Seiichi
Middle name
Last name Yoshimoto
Organization Japan Society for Head and Neck Cancer
Division name Cancer Registry Committee
Zip code 135-0033
Address 2-4-11 Fukagawa Kotoh-ku, Tokyo 135-0033 Japan
TEL 03-5620-1953
Email hnc-admin@umin.ac.jp

Public contact
Name of contact person
1st name Seiichi
Middle name
Last name Yoshimoto
Organization Japan Society for Head and Neck Cancer
Division name Cancer Registry Committee
Zip code 1040045
Address 2-4-11 Fukagawa Kotoh-ku, Tokyo 135-0033 Japan
TEL 03-5620-1953
Homepage URL
Email hnc-admin@umin.ac.jp

Sponsor
Institute Japan Society for Head and Neck Cancer
Institute
Department

Funding Source
Organization Japan Society for Head and Neck Cancer
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 Japan Society for Head and Neck Cancer
Address 2-4-11 Fukagawa Kotoh-ku, Tokyo 135-0033 Japan
Tel 0356201953
Email jshnc-service@onebridge.co.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
2018 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 04 Month 12 Day
Date of IRB
2018 Year 04 Month 23 Day
Anticipated trial start date
2012 Year 05 Month 25 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All doctors who are member of the Japan Society for Head and Neck Cancer, are able to participate in the registration. The completed registration provides information regarding the patient's age, gender, tumor pathology, TNM classification, therapies and prognosis. Registration is restricted to previously untreated malignant head and neck tumor cases and in the treated year between 2011 and 2020.

Management information
Registered date
2018 Year 05 Month 02 Day
Last modified on
2020 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036178

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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