UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032465 |
|---|---|
| Receipt number | R000036178 |
| Scientific Title | The Head and Neck Cancer Registry in Japan |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2023/05/10 13:06:46 |
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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, major salivary glands and unknown primary.
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
220000
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kawakita |
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
hnc-admin@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kawakita |
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
hnc-admin@umin.ac.jp
Sponsor or person
Institute
Japan Society for Head and Neck Cancer
Institute
Department
Personal name
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
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
| 2021 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2031 | 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 2031.
Management information
Registered date
| 2018 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.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 |
