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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041785
Receipt No. R000047691
Scientific Title Treatment of laryngeal cancer in Japan
Date of disclosure of the study information 2020/09/15
Last modified on 2020/09/14

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Basic information
Public title Variation of treatment decision-making for laryngeal cancer in Japan a retrospective observational study using a nationalwide database
Acronym Treatment of laryngeal cancer in Japan
Scientific Title Treatment of laryngeal cancer in Japan
Scientific Title:Acronym Treatment of laryngeal cancer in Japan
Region
Japan

Condition
Condition Laryngeal cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the variation of treatment decision-making for laryngeal cancer in Japan
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Type of initial treatment
Key secondary outcomes Regimens of radiotherapy

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
20 years-old <=
Age-upper limit
200 years-old >
Gender Male and Female
Key inclusion criteria Patients were identified using Diagnosis Procedure Combination (DPC) data, and target ICD-10 (C320, C321, C322, C329)
Key exclusion criteria T4, N3, or M1 cases, as well as patients with unclear T stage, were excluded. Patients who had surgeries with Japanese procedure code C112 (tracheostomy), K394-2 (laryngectomy), K395 (pharyngolaryngectomy), K403-2-4 (laryngotracheal separation), and K403-2-3 (total laryngectomy for aspiration) before the index date, were also excluded.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Fujiwara
Organization Kurashiki Central Hospital
Division name Otolaryngology
Zip code 7108602
Address Miwa 1-1-1, Kurashiki city, Okayama, Japan
TEL 086-422-0210
Email t.fujiwarabi@gmail.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Fujiwara
Organization Kurashiki Central Hospital
Division name Otolaryngology
Zip code 7108602
Address Miwa 1-1-1, Kurashiki city, Okayama, Japan
TEL 086-422-0210
Homepage URL
Email t.fujiwarabi@gmail.com

Sponsor
Institute Kurashiki Central Hospital
Institute
Department

Funding Source
Organization Kurashiki Central Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kurashiki Central Hospital
Address Miwa 1-1-1, Kurashiki city, Okayama, Japan
Tel 086-422-0210
Email tf14817@kchnet.or.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 09 Month 15 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 363
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 No longer recruiting
Date of protocol fixation
2019 Year 09 Month 30 Day
Date of IRB
2019 Year 10 Month 31 Day
Anticipated trial start date
2019 Year 10 Month 31 Day
Last follow-up date
2019 Year 10 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 medical database study using RWD database from HCEI. The dataset for this study was cut from the database in September 2019.

Management information
Registered date
2020 Year 09 Month 14 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047691

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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