UMIN-CTR Clinical Trial

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	Unpublished
Publication of results	Unpublished

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/ace/3/3/3_No.21-12/_article/-char/ja
Number of participants that the trial has enrolled	363
Results	Larynx-preserving treatment was used in most T1 and T2 cases (96.9%), and 40% of the patients with T3 cancer underwent total laryngectomy (adjusted odds ratio 26.7 [95% CI, 9.29-91.6]).
Results date posted	2021 Year 07 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 07 Month 01 Day
Baseline Characteristics	Mean age(year) 71.8 Gender(male/female) 333/30
Participant flow	Extracted from Database
Adverse events	Not evaluated
Outcome measures	Treatment pattern
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2021 Year 09 Month 15 Day

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